IFU is not found for this 510(k).
| 510(k) Number | Device Name | Applicant | Decision Date | Procode |
|---|---|---|---|---|
| K251604 | CareSuperb COVID-19/Flu A&B Antigen Combo Home Test |
Access Bio, Inc. | 08/22/2025 | SCA |
| K243692 | EnDrive (EnDriveUS) | Advanced Technology Research (A.T.R.) s.r.l. |
08/22/2025 | EKX |
| K252302 | CARTO™ 3 EP Navigation System V8.1 |
Biosense Webster, Inc. | 08/22/2025 | DQK |
| K243660 | Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject™ 3mL Syringe, Luer-Lock Tip (1180300777); Monoject™ 6mL Syringe, Luer-Lock Tip (1180600777); Monoject™ 12mL Syringe, Luer-Lock Tip (1181200777); Monoject™ 20mL Syringe, Luer-Lock Tip (1182000777); Monoject™ 35mL Syringe, Luer-Lock Tip (1183500777); Monoject™ 60mL Syringe, Luer-Lock Tip (1186000777); Monoject™ 3mL Syringe, Luer-Lock Tip (8881513934); Monoject™ 6mL Syringe , Luer-Lock Tip (8881516937); Monojec |
Cardinal Health | 08/22/2025 | FMF |
| K250147 | CPS Locator 3D Delivery Catheter |
CenterPoint Systems | 08/22/2025 | DQY |
| K251828 | CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set |
Cerenovus Inc. | 08/22/2025 | NRY |
| K251443 | PROMO | DRGEM Corporation | 08/22/2025 | IZL |
| K252362 | GBrain MRI | Galileo CDS, Inc | 08/22/2025 | QIH |
| K251884 | One-Fil Putty Injectable | MEDICLUS CO., LTD. | 08/22/2025 | KIF |
| K251277 | CoraForce Microcatheter, CoraFlex Microcatheter |
Reflow Medical, Inc. | 08/22/2025 | DQY |
| K251192 | Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic Ultrasound System (Vaus7); Diagnostic Ultrasound System (Zeus); Diagnostic Ultrasound System (ME7); Diagnostic Ultrasound System (Anesus ME7); Diagnostic Ultrasound System (Anesus ME7T); Diagnostic Ultrasound System (MX7P); Diagnostic Ultrasound System (MX7W); Diagnostic Ultrasound System (MX8); Diagnostic Ultrasound System (MX8T); Diagnostic Ultrasound System (Vaus8); Diagnostic Ultrasound System (ME8) |
Shenzhen Mindray Bio-medical Electronics Co., LTD. |
08/22/2025 | IYN |
| K243685 | MammoScreen BD | Therapixel | 08/22/2025 | QIH |
| K252303 | Stem Extension Line (USTAR II System) |
United Orthopedic Corporation |
08/22/2025 | KRO |
| K252356 | The Acumed Wrist Fixation System - 2.4mm Screws |
Acumed LLC | 08/21/2025 | |
| K251579 | VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 Μg/ml) |
bioMerieux, Inc. | 08/21/2025 | LON |
| K250923 | Fine Osteotomy™ | Bodycad Laboratories Inc. |
08/21/2025 | |
| K251647 | MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System |
Dentsply Sirona Inc. | 08/21/2025 | DZE |
| K252244 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric Acid, Fentanyl In Gastric Acid And Xylazine In Gastric Acid |
Ever Global (Vietnam) Enterprise Corporation |
08/21/2025 | LZA |
| K250994 | ClearTip FNA And FNB Types | FINEMEDIX Co., Ltd. | 08/21/2025 | FCG |
| K251130 | Portable Oxygen Concentrator (JM-P50A) |
Jiangsu Jumao X-Care Medical Equipment Co., Ltd. |
08/21/2025 | CAW |
| K243965 | Origin™ | NERv Technology Inc. (D.B.A.) FluidAI Medical |
08/21/2025 | SFO |
| K251588 | LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) |
Shenzhen Fittop Health Technology Co., Ltd. |
08/21/2025 | OHS |
| K250784 | Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122) |
Shenzhen Yicai Health Technology Co. Ltd |
08/21/2025 | NUH |
| K241152 | InSee | Tidal Medical Technologies LLC |
08/21/2025 | BWF |
| K251135 | Treace Medical Concepts (TMC) Implant Fixation System |
Treace Medical Concepts | 08/21/2025 | |
| K251029 | Vista OS, Vista AI Scan, RTHawk |
Vista AI, Inc. | 08/21/2025 | LNH |
| K251837 | Salix Coronary Plaque (V1.0.0) | Artrya Limited | 08/20/2025 | QIH |
| K243804 | MicroScan Dried Gram-Negative MIC/Combo Panels With Cefepime (CPE) (0.12-64 Μg/ml) (MicroScan) |
Beckman Coulter, Inc. | 08/20/2025 | LTT |
| K252104 | T1D1 | Comerge AG | 08/20/2025 | NDC |
| K251471 | IPD Dental Implant Abutments | IMPLANT PROTESIS DENTAL 2004, S.L. |
08/20/2025 | NHA |
| K251580 | MTS Sulbactam-Durlobactam 0.004/4 - 64/4 Μg/ml (SUD) |
Liofilchem s. r. l. | 08/20/2025 | JWY |
| K251590 | Methinks CTA Stroke | Methinks Software S.L. | 08/20/2025 | QAS |
| K250417 | Remanufactured EndoWrist Cobra Grasper (420190) |
Rebotix | 08/20/2025 | QSM |
| K250383 | Wearable Breast Pump (Model W6) |
Shenzhen TPH Technology Co., Ltd. |
08/20/2025 | HGX |
| K251481 | ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc. |
08/20/2025 | IYN |
| K251229 | EndoFix™Tissue Fixation System |
SofTac Medical Technologies |
08/20/2025 | FGE |
| K251400 | T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System |
Stryker GmbH | 08/20/2025 | HSB |
| K252061 | Distal Xtremities System | TriMed, Inc. | 08/20/2025 | HRS |
| K251563 | WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test |
Wondfo USA Co., Ltd. | 08/20/2025 | SCA |
| K250721 | LOCATOR® Angled Abutment | Zest Anchors, LLC | 08/20/2025 | NHA |
| K243713 | Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A) |
Agnes Medical Co., Ltd | 08/19/2025 | GEI |
| K250313 | Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs And Gastric Acid |
HARPS Europe Manufacturing GmbH |
08/19/2025 | KGO |
| K252022 | OSSIOfiber® Interference Screw |
OSSIO Ltd. | 08/19/2025 | MAI |
| K250387 | Remanufactured EndoWrist Long Tip Forceps (420048) |
Rebotix | 08/19/2025 | QSM |
| K250399 | Remanufactured EndoWrist Cadiere Forceps (420049) |
Rebotix | 08/19/2025 | |
| K250539 | Remanufactured EndoWrist Tenaculum Forceps (420207) |
Rebotix | 08/19/2025 | QSM |
| K252316 | Venclose Digirf Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100) |
Venclose, Inc. | 08/19/2025 | GEI |
| K251086 | PnueAira (PNCU-01) | BioTAB, LLC | 08/18/2025 | JOW |
| K250167 | Evolution Spine Navigation Instruments |
Evolution Spine | 08/18/2025 | OLO |
| K251161 | ANTHEM® Fracture System | Globus Medical, Inc. | 08/18/2025 | HRS |
| K250271 | Neodent Implant System - Zirconia Implant System |
JJGC Indústria e Comércio de Materiais Dentários S.A. |
08/18/2025 | DZE |
| K243539 | Apollo TMS Therapy System | MAG & More GmbH | 08/18/2025 | OBP |
| K243604 | Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate And Fentanyl Citrate In Simulated Gastric Acid |
O&M Halyard, Inc. | 08/18/2025 | LZA |
| K251913 | OsteoCentric® UnifiMI® TCS Plating System |
OsteoCentric Technologies |
08/16/2025 | HRS |
| K252259 | AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup |
Assure Tech LLC | 08/15/2025 | NFT |
| K251969 | Atlas Spine Project X Expandable Posterior Lumbar Interbody System |
Atlas Spine, Inc. | 08/15/2025 | MAX |
| K250036 | MicroScan Dried Gram-Positive MIC/Combo Panels With Daptomycin (DAP) (0.06-32 Μg/ml) |
Beckman Coulter, Inc. | 08/15/2025 | LTT |
| K250170 | PHAROS | Brightonix Imaging | 08/15/2025 | KPS |
| K250867 | Dunamis Screw And Suture Locking System |
Dunamis Medical, LLC | 08/15/2025 | HWC |
| K251747 | VEA Align; Spineeos | EOS imaging | 08/15/2025 | QIH |
| K243851 | CHLOE BLAST | Fairtility Ltd. | 08/15/2025 | PBH |
| K251972 | Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180) |
Healgen Scientific LLC | 08/15/2025 | DJG |
| K251871 | FEATHER 01 02 03 04 (Model:01) | Heat In A Click LLC. | 08/15/2025 | OHS |
| K250397 | Helios Dermal Scaffold | Helios Biomedical Inc. | 08/15/2025 | KGN |
| K243650 | Zio® Monitor (DFG0001) | iRhythm Technologies, Inc. |
08/15/2025 | DSH |
| K251877 | JMS CAVEO A.V. Fistula Needle Set |
JMS North America Corporation |
08/15/2025 | FIE |
| K250620 | KLS Martin Ixos System | KLS Martin L.P. | 08/15/2025 | HRS |
| K252236 | CP Relief Wand Rx - TENS/NMES | N & C Holdings, LLC | 08/15/2025 | GZJ |
| K251243 | OneRF Trigeminal Nerve Radiofrequency Probes |
NeuroOne Medical Technologies Corp. |
08/15/2025 | GXI |
| K250818 | Nerveblox | Smart Alfa Teknoloji San. Ve Tic. A.S. |
08/15/2025 | QRG |
| K251834 | Persona Partial Knee | Zimmer Biomet | 08/15/2025 | HSX |
| K243544 | BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini |
BioFire Diagnostics, LLC | 08/14/2025 | QOF |
| K243600 | 3nethra Neo HD FA; 3nethra Neo HD |
FORUS HEALTH PVT.LTD., | 08/14/2025 | HKI |
| K251062 | Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi Pack |
Geistlich Pharma AG | 08/14/2025 | NPL |
| K243905 | Stitch Cerclage – Suture Tapes |
GM Dos Reis Industria e Comercio Ltda. |
08/14/2025 | JDQ |
| K250164 | Cassette Autoclave (ACA5) | Guangzhou Ajax Medical Equipment Co., Ltd. |
08/14/2025 | FLE |
| K251526 | FilmArray GI Control Panel M238 |
Maine Molecular Quality Controls, Inc. |
08/14/2025 | PMN |
| K243437 | Mom Essential Incubator (ME1) | Mom Incubators Limited | 08/14/2025 | FMZ |
| K251012 | TRUDERMAL Pro (ZLD-390) | Shenzhen Kaiyan Medical Equipment Co., Ltd |
08/14/2025 | OHS |
| K250916 | WinForth (LM-E470KA) | Shenzhen Leaflife Technology Co., Ltd. |
08/14/2025 | PBX |
| K251176 | IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A, T22B, T25B, T25C) |
Shenzhen Mlay Intelligent Technology Co., Ltd. | 08/14/2025 | OHT |
| K250898 | Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears With Advanced Hemostasis X 23cm); Reprocessed HARMONIC 700 Shears (HAR736/Reprocessed HARMONIC 700, 5mm Diameter Shears With Advanced Hemostasis X 36cm); Reprocessed HARMONIC 700 Shears (HAR745/Reprocessed HARMONIC 700, 5mm Diameter SHears With Advanced Hemostasis X 45cm) |
Stryker Sustainability Solutions |
08/14/2025 | NLQ |
| K251519 | RelieVRx (Pico G3) | AppliedVR | 08/13/2025 | QRA |
| K250841 | Electrotherapy Electrodes | Baisheng Medical Co., Ltd. |
08/13/2025 | GXY |
| K251495 | MBT Compass HT CA Software; MBT FAST Shuttle US IVD |
Bruker Daltonics GmbH & Co. KG |
08/13/2025 | QBN |
| K243279 | DOLORCLAST Focused Shock Waves | E.M.S. Electro Medical Systems S.A. |
08/13/2025 | PZL |
| K252192 | Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25) |
HuiZhou LVB Maternal and Infant Supplies Co., Ltd. |
08/13/2025 | HGX |
| K243653 | KARL STORZ HOPKINS Telescopes For Urology |
Karl Storz SE & Co. KG | 08/13/2025 | FAJ |
| K252226 | Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 Cm (320102) |
Nuwellis, Inc. | 08/13/2025 | NQJ |
| K251569 | Bone Screw | Osstem Implant Co., Ltd. | 08/13/2025 | DZL |
| K243579 | AeroJet Ventilation Catheter | Pipeline Medical Products, LLC |
08/13/2025 | BTR |
| K252201 | HS Fiber | Riverpoint Medical | 08/13/2025 | GAT |
| K251046 | S.I.N. Dental Implant System | S.I.N. Implant System LTDA. |
08/13/2025 | DZE |
| K250163 | T2 Alpha Femur Retrograde Nailing System |
Stryker GmbH | 08/13/2025 | HSB |
| K251033 | Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Compact Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons |
Unibeauty (Hubei) Technology Co.,Ltd. |
08/13/2025 | HEB |
| K250931 | Unimed Reusable SpO2 Sensors (-117 And -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 And -121 Series) (U103-117); Unimed Reusable SpO2 Sensors (-117 And -121 Series) (U410-121); Unimed Reusable SpO2 Sensors (-117 And -121 Series) (U110-121) |
Unimed Medical Supplies, Inc. |
08/13/2025 | DQA |
| K252083 | HOTWIRE™ System RF Generator And Footswitch (optional Accessory) |
Atraverse Medical, Inc. | 08/12/2025 | GEI |
| K250755 | DS Core Diagnosis | Dentsply Sirona Inc. | 08/12/2025 | QIH |
| K251494 | Eko Foundation Analysis Software With Transformers (EFAST) |
Eko Health, Inc. | 08/12/2025 | DQD |
| K243562 | CuffGuard | Idmed | 08/12/2025 | BSK |
| K250294 | Straumann® RidgeFit Implants | Institut Straumann AG | 08/12/2025 | DZE |
| K251879 | Sulopenem SPM 2 Μg | Liofilchem | 08/12/2025 | JTN |
| K250836 | 14F Duo-Flow® Side X Side Double Lumen Catheter |
Medical Components, Inc | 08/12/2025 | MPB |
| K250207 | Eufy Wearable Breast Pump S1 (T8DO2); Eufy Wearable Breast Pump E10 (T8DO3) |
Anker Innovations Limited |
08/11/2025 | HGX |
| K251245 | OxyMinder Pro (10310) | Bio-Med Device, Inc. | 08/11/2025 | CCL |
| K252211 | Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH) |
CnC Technologies | 08/11/2025 | GEI |
| K251873 | Saige-Dx | DeepHealth, Inc. | 08/11/2025 | QDQ |
| K251327 | XERF | Lutronic Corporation | 08/11/2025 | GEI |
| K232456 | RW-1 | Mediott Inc. | 08/11/2025 | LLZ |
| K251862 | External Fixation Bone Distractor |
Paragon 28, Inc. | 08/11/2025 | KTT |
| K241731 | Outlook Surgical Versa One System (8900139) |
ResnENT, LLC | 08/11/2025 | EOB |
| K251125 | MagVenture TMS Therapy System | Tonica Elektronik A/S | 08/11/2025 | OBP |
| K250462 | UL UHD-Clear View 4K Camera System (UL-3Chip 4K) |
Univlabs Technologies Private Limited |
08/11/2025 | FET |
| K251823 | UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE BRONCHO Single-Use Bronchoscopes (EBS-500C); UE BRONCHO Single-Use Bronchoscopes (EBS-600C); UE Display (UE-M10S) |
Zhejiang UE Medical Corp. |
08/11/2025 | EOQ |
| K251098 | Identity Revision Humeral Stems |
Zimmer Inc. | 08/11/2025 | MBF |
| K250472 | SixFix™ Hexapod Fixator And Deformity Analysis And Correction Software (DACS) |
AMDT Holdings, Inc | 08/08/2025 | KTT |
| K251226 | Aqua Medical RF Vapor Ablation System |
Aqua Medical, Inc. | 08/08/2025 | KNS |
| K251713 | BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 Μg/ml) |
Becton, Dickinson and Company |
08/08/2025 | LON |
| K243395 | MICOR 700 With Auto I/A | Carl Zeiss Meditec Cataract Technology Inc. |
08/08/2025 | HQC |
| K250540 | SABER-C System | Elevation Spine | 08/08/2025 | OVE |
| K250718 | Swiftpro System (SWF-SPS); Swift System (SWF-SYS) |
Emblation Limited | 08/08/2025 | NEY |
| K243972 | Plain Water-based Lubricant | Global Protection Corp. | 08/08/2025 | NUC |
| K250142 | Water-based Lubricant | Global Protection Corp. | 08/08/2025 | NUC |
| K252176 | Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) |
Guangzhou Red Pine Medical Instrument Co., Ltd. |
08/08/2025 | FAJ |
| K251801 | Diode Laser Device (BM091) | Hebei Newangie Technology Co., Ltd |
08/08/2025 | GEX |
| K243531 | Codman Libertís Shunt Catheter With Bactiseal And Endexo Technology |
Integra LifeSciences Production Corporation |
08/08/2025 | JXG |
| K252170 | OptiVu™ Shoulder | MR Surgical Solutions, LLC |
08/08/2025 | SBF |
| K243254 | Parkell Pit And Fissure Sealant |
Parkell, Inc. | 08/08/2025 | EBC |
| K251119 | MagVenture TMS Therapy System | Tonica Elektronik A/S | 08/08/2025 | OBP |
| K250817 | Coretech Compression System (Coretech RHB3003) |
Vive Health LLC | 08/08/2025 | JOW |
| K251247 | GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest Of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03) |
Boston Scientific Neuromodulation Corporation |
08/07/2025 | GXD |
| K250309 | BTL-199 | BTL Industries, Inc. | 08/07/2025 | QPL |
| K251629 | UNiD™ Spine Analyzer | Medicrea International S.A.S. (Medtronic) |
08/07/2025 | QIH |
| K250622 | Succession™ AFN System | Ortho Solutions UK Ltd. | 08/07/2025 | HSB |
| K243765 | LuMon(TM) System | Sentec AG | 08/07/2025 | QEB |
| K251667 | LED Light Therapy Mask (M01, M02, M06, M07, M08, M09) |
Shenzhen Liyoutong Technology Co., Ltd. |
08/07/2025 | OHS |
| K243021 | Longboard Revision Hip Stem | Signature Orthopaedics Pty Ltd. |
08/07/2025 | LZO |
| K250664 | Navigo Workstation 2.3 (FPRMC00039) |
UC-CARE Ltd. | 08/07/2025 | LLZ |
| K242895 | Aevumed PHANTOM Suture Anchors | Aevumed, Inc. | 08/06/2025 | MBI |
| K251432 | Olo | El.En. S.p.A. | 08/06/2025 | GEX |
| K250124 | Viction Disposable Irrigation And Suction Catheter (VC-IRA0532, VC-IRA0523, VC-IRB0532, VC-IRB0523, VC-IRC0532, VC-IRC0523, VC-IRD0532, VC-IRD0532) |
Hangzhou Viction Medical Technology Co.,Ltd |
08/06/2025 | GCJ |
| K250130 | Viction Disposable Irrigation And Suction System (VC-FLA0514; VC-FLA0523; VC-FLA0532; VC-FLB0514; VC-FLB0523; VC-FLB0532; VC-FLC0514; VC-FLC0523; VC-FLC0532; VC-FLD0514; VC-FLD0523; VC-FLD0532) |
Hangzhou Viction Medical Technology Co.,Ltd |
08/06/2025 | GCJ |
| K252239 | InVision™ 3T Recharge Operating Suite |
IMRIS Imaging, Inc. | 08/06/2025 | LNH |
| K243552 | Codman Libertís™ 1.5 Mm EVD Catheter With Bactiseal® And Endexo® Technology With Luer Connection (821761); Codman Libertís™ 1.9 Mm EVD Catheter With Bactiseal® And Endexo® Technology With Luer Connection (821762) |
Integra LifeSciences Production Corporation |
08/06/2025 | JXG |
| K251120 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B) |
Microlife Corporation | 08/06/2025 | DXN |
| K250569 | Cardiologs Holter Platform | Philips France Commercial |
08/06/2025 | DPS |
| K251038 | Digital Radiographic Imaging Acquisition Software - DR (RiasDR) |
Shen Zhen Cambridge-hit Co., Ltd. |
08/06/2025 | LLZ |
| K251854 | SteadiSet Infusion Set | Tandem Diabetes Care | 08/06/2025 | FPA |
| K252326 | InterSpace GV Hip Spacer | Tecres S.p.A. | 08/06/2025 | KWL |
| K252113 | PRADO™ Lumbar Interbody Fusion System |
Bethesda Medical Devices | 08/05/2025 | MAX |
| K244016 | Ipetcertum (v1.0) | Claritas HealthTech Pte Ltd |
08/05/2025 | LLZ |
| K252141 | AltiVate Reverse® Glenoid | Encore Medical L.P. | 08/05/2025 | PHX |
| K250434 | Trophon2 | Nanosonics | 08/05/2025 | OUJ |
| K250934 | Respiree Cardio- Respiratory Monitor System |
Respiree PTE LTD | 08/05/2025 | BZQ |
| K250246 | Umr Jupiter | Shanghai United Imaging Healthcare Co., Ltd. |
08/05/2025 | LNH |
| K251411 | Chemfort Female Luer Lock Adaptor |
Simplivia Healthcare LTD. |
08/05/2025 | ONB |
| K251113 | Ihealth Compare Wireless Blood Pressure Monitor(BP-300C);iHealth Compare Pro Wireless Blood Pressure Monitor(BP-300CV);iHealth Compare S Wireless Blood Pressure Monitor(BP-300V);iHealth Wireless Blood Pressure Monitor(BPX1);iHealth Blood Pressure Monitor(KD-595);iHealth Track Pro Connected Blood Pressure Monitor(KN-550LT);Semi Automatic Blood Pressure Monitor(KD-388N);Arm Blood Pressure Monitor(KD-553);Arm Blood Pressure Monitor(KD-557BR);Arm Blood Pressure Monitor(KD-558);Arm Blood Pr |
Andon Health Co., Ltd. | 08/04/2025 | DXN |
| K251087 | Blood Volume Analyzer (200) | Daxor Corporation | 08/04/2025 | |
| K251223 | HnX-P1, HnX-PB | H&abyz Co., Ltd. | 08/04/2025 | IZL |
| K250950 | CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739) |
Okapi Medical LLC dba Resivant Medical |
08/04/2025 | MPN |
| K251762 | Quantum Perfusion Centrifugal Blood Pump CP20NG With Integrated Sensors (CP20V-NG) |
Spectrum Medical S.r.l. | 08/04/2025 | KFM |
| K251122 | Terragene® Bionova® BT20 Biological Indicator |
Terragene | 08/04/2025 | FRC |
| K243458 | HydroPICC 4Fr Single Lumen Marked Catheter, 130 Cm Guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked Catheter, 70 Cm Guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked Catheter - Maximal Barrier Kit (70001304); HydroPICC 5Fr Dual Lumen Marked Catheter, 130 Cm Guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked Catheter, 70 Cm Guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked Catheter - Maximal Barrier Kit (70002304); Hydr |
Access Vascular, Inc. | 08/01/2025 | LJS |
| K250315 | RONAVIS – FX (FX-001) | AIRS Inc. | 08/01/2025 | HTY |
| K251652 | Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, STS-2040-302AA HD-endoscope, STS-2040-302BA HD-endoscope, STS-2040-302BSA HD-endoscope, STS-2040-302ESA HD-endoscope, STS-2040-302CA HD-endoscope, STS-2029-302AA HD-endoscope, STS-2029-302BA HD-endoscope, STS-2040-298DSA-RWF-endoscope, STS-2040-298ASA-RWF-endoscope, STS-2040-300GSA-RWF-endoscope, STS-2040-303CA-RWF-endoscope, STS-2040-280ASA-OLY-endoscope, STS-2040-280ESA-OLY-endoscope, STS-2040-283BSA-OLY-endo |
American Medical Endoscopy, Inc. (DBA Strauss Surgical) |
08/01/2025 | FAJ |
| K250495 | MINI VP1 (PL67_F); MINI VP1 (PL61_F) |
Avizor S.A. | 08/01/2025 | LRX |
| K243483 | Access Hstni | Beckman Coulter Inc. | 08/01/2025 | MMI |
| K250381 | Deepsight NeedleVue LC1 Ultrasound System |
DeepSight Technology, Inc. |
08/01/2025 | IYO |
| K243841 | Sparta Infusion Set For Insulin |
DEKA Research and Development |
08/01/2025 | FPA |
| K243427 | QuickSleeper 5 | Dentalhitec | 08/01/2025 | EGM |
| K243462 | Diazyme Colorimetric Lithium Assay |
Diazyme Laboratories, Inc. |
08/01/2025 | NDW |
| K250790 | INNOVISION-DXII | DK MEDICAL SYSTEMS Co., Ltd |
08/01/2025 | KPR |
| K252094 | Ezsure™ Empty Fluid Container |
Epic Medical Pte. Ltd. | 08/01/2025 | KPE |
| K243448 | Equinoxe® Shoulder System | Exactech Inc. | 08/01/2025 | PHX |
| K250941 | Revolution Vibe | GE Medical Systems, LLC | 08/01/2025 | JAK |
| K250541 | Self-Forming Magnet (Flexagon Plus OTOLoc) |
GI Windows, Inc. | 08/01/2025 | SAH |
| K243496 | MycoMEIA Aspergillus Assay | Pearl Diagnostics, Inc. | 08/01/2025 | NOM |
| K251252 | NOBILCAM IMPAK Disc | Shandong Huge Dental Material Corporation |
08/01/2025 | MQC |
| K251707 | IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L) |
Shenzhen Huachuangtong Industrial Co., Ltd. |
08/01/2025 | OHT |
| K250508 | AK 98 Dialysis Machine (955607) |
Vantive US Healthcare LLC |
08/01/2025 | KDI |
| K243571 | Trabecular Metal Acetabular Revision System, Acetabular Liners And Constrained Liners |
Zimmer Biomet | 07/31/2025 | JDI |
| K243656 | U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella |
United Orthopedic Corporation |
07/31/2025 | MBH |
| K251561 | Biograph Trinion | Siemens Medical Solutions USA, Inc. |
07/31/2025 | KPS |
| K250738 | YSIO X.pree | Siemens Medical Solutions |
07/31/2025 | KPR |
| K250843 | Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) |
Shenzhen TPH Technology Co., Ltd. |
07/31/2025 | HGX |
| K242728 | BeneVision Central Monitoring System |
Shenzhen Mindray Bio-medical Electronics Co., LTD. |
07/31/2025 | MSX |
| K243455 | Cobas Respiratory 4-flex For Use On The Cobas 5800/6800/8800 Systems |
Roche Molecular Systems, Inc. |
07/31/2025 | QOF |
| K250597 | REMEX Xcam6 | REMEDI Inc. | 07/31/2025 | IZL |
| K250477 | NextAR(TM) Spine | Medacta International S.A. |
07/31/2025 | SBF |
| K241461 | Mpact Constrained Liner | Medacta International S.A. |
07/31/2025 | KWZ |
| K244060 | Eco2 3D | Lutronic Corporation | 07/31/2025 | ONG |
| K243341 | Genius AI Detection 2.0 | Hologic, Inc. | 07/31/2025 | QDQ |
| K251574 | Sleep Watch | Ambulatory Monitoring, Inc. |
07/31/2025 | LEL |
| K251361 | Tyber Medical Distal Radius Plating System |
Tyber Medical LLC. | 07/30/2025 | HRS |
| K250127 | TSK Syringe | TSK Laboratory, Japan | 07/30/2025 | QNQ |
| K252032 | T65 (9016E061-) | Tonica Elektronik A/S | 07/30/2025 | OBP |
| K243534 | Micro Catheter | Suzhou Zenith Vascular SciTech Limited |
07/30/2025 | KRA |
| K250724 | Intraosseous Infusion Needles | Spectrum Vascular | 07/30/2025 | FMI |
| K251076 | Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E) |
Shenzhen Lifotronic Technology Co., Ltd. |
07/30/2025 | GEX |
| K252144 | Iconix Speed Anchor; Iconix Speed HA+ Anchor |
Riverpoint Medical | 07/30/2025 | MBI |
| K251060 | CORUS™ Navigation System-GX | Providence Medical Technology, Inc. |
07/30/2025 | OLO |
| K241990 | SpineSite Endoscope System | HydroCision, Inc. | 07/30/2025 | HRX |
| K243919 | Voxel Dosimetry (00859873006226) |
Hermes Medical Solutions AB |
07/30/2025 | QIH |
| K251319 | Sterile Nitrile Powder Free Examination Glove Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue); Sterile Nitrile Powder Free Examination Glove Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue) – Extended Cuff |
Hartalega NGC Sdn. Bhd. | 07/30/2025 | LZA |
| K242855 | P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) |
E.O.S Co., Ltd. | 07/30/2025 | LPL |
| K251706 | TENS And EMS Unit | Changsha Anxiang Medical Technology Co., LTD. |
07/30/2025 | NGX |
| K244007 | ArteVu | Cardio Ring Technologies, Inc. Taiwan Branch |
07/30/2025 | DXN |
| K251735 | Stabilis SA Cervical Stand-Alone System (Various PNs) |
Acuity Surgical Devices LLC |
07/30/2025 | OVE |
| K251234 | EnSite™ X EP System | Abbott Medical | 07/30/2025 | DQK |
| K243407 | Forcyte Autograft Harvest Kit | Forcyte Medical LLC | 07/29/2025 | KNW |
| K251364 | Sleepiz One+ (2.5) | Sleepiz AG | 07/29/2025 | DRT |
| K250647 | SImmetry+ System | SiVantage | 07/29/2025 | OUR |
| K251523 | Cios Spin | Siemens Medical Solutions USA, Inc |
07/29/2025 | OWB |
| K243473 | PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS |
Prognosys Medical Systems Private Limited |
07/29/2025 | IZL |
| K251664 | Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022) |
Olympus Medical Systems Corporation |
07/29/2025 | KTI |
| K250442 | Da Vinci Surgical System, IS5000 |
Intuitive Surgical Inc. | 07/29/2025 | NAY |
| K250356 | MoMe ARC® Wireless Ambulatory ECG Monitoring And Detection System (32000) |
InfoBionic, Inc. | 07/29/2025 | DSI |
| K250179 | Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) |
Edan Instruments Inc. | 07/29/2025 | MHX |
| K251350 | BD Plastipak™ Syringe | Becton, Dickinson and Company |
07/29/2025 | FMF |
| K251061 | NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime |
Siemens Medical Solutions USA, Inc. |
07/28/2025 | JAK |
| K241183 | ISO Abutment | SEUM Medi Co., Ltd. | 07/28/2025 | NHA |
| K251220 | NUVENTUS NV.C™ Prosthetic Components |
Infinitum Eta Ltd. | 07/28/2025 | NHA |
| K251187 | 3 In 1 TENS UNIT (TC1241, TC2241, TS1241) |
Changsha Anxiang Medical Technology Co., Ltd |
07/28/2025 | NUH |
| K251640 | SIGMA Spectrum Infusion Pump With Master Drug Library |
Baxter Healthcare Corporation |
07/28/2025 | FRN |
| K251636 | Spectrum IQ Infusion System With Dose IQ Safety Software (3570009) |
Baxter Healthcare Corporation |
07/28/2025 | FRN |
| K250652 | ECG-AI Low Ejection Fraction (LEF) 12-Lead Algorithm (1010) |
Anumana, Inc. | 07/28/2025 | QYE |
| K243489 | Alinity M EBV (09N43-095) | Abbott Molecular Inc. | 07/28/2025 | QLX |
| K251620 | A.L.P.S. Proximal Humerus Plating System |
Zimmer Biomet | 07/25/2025 | HRS |
| K251339 | Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) |
Zhengzhou PZ Laser Slim Technology Co., Ltd. |
07/25/2025 | GEX |
| K250970 | Marie | Leo Cancer Care | 07/25/2025 | JAK |
| K250334 | Fusion Craniofacial Implant; Fusion Skull Implant |
Kelyniam Global Inc. | 07/25/2025 | GWO |
| K252215 | InbellaMAX System | Inbella Medical Ltd. | 07/25/2025 | GEI |
| K250232 | Vathin® Video Bronchoscope System |
Hunan Vathin Medical Instrument Co., Ltd. |
07/25/2025 | EOQ |
| K251665 | Triathlon® Hinge Knee System | Howmedica Osteonics Corp. dba Stryker Orthopaedics |
07/25/2025 | KRO |
| K250989 | Stryker And Serf Hip Devices | Howmedica Osteonics Corp (dba Stryker Orthopaedics) |
07/25/2025 | LPH |
| K250244 | Compression Therapy Device (LGT-2210DS) |
Guangzhou Longest Medical Technology Co., Ltd. |
07/25/2025 | IRP |
| K243244 | Heated Breathing Tube | GuangDong EDA Technology Co., Ltd |
07/25/2025 | BZE |
| K250859 | TransForm McCarthy Mitral Annuloplasty Ring (TF) |
Genesee Biomedical Inc | 07/25/2025 | KRH |
| K251322 | Venue; Venue Go; Venue Fit; Venue Sprint |
GE Medical Systems Ultrasound and Primary care Diagnostics, |
07/25/2025 | IYN |
| K252033 | Profoject™ Disposable Syringe, Profoject™ Disposable Syringe With Needle |
CMT HEALTH PTE. LTD. | 07/25/2025 | FMF |
| K243403 | BD Nexiva™ Closed IV Catheter System |
Becton Dickinson Infusion Therapy Systems Inc. |
07/25/2025 | FOZ |
| K250552 | Hi-Torque Command 14 ST Guide Wire And Hi-Torque Command 14 MT Guide Wire |
Abbott Medical | 07/25/2025 | DQX |
| K243711 | Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580); |
Wuxi Hisky Medical Technologies Co., Ltd. |
07/24/2025 | OWN |
| K250284 | TSK SELECT™ Needle | TSK Laboratory, Japan | 07/24/2025 | FMI |
| K252010 | SPY Laparoscope | Stryker Endoscopy | 07/24/2025 | GCJ |
| K251984 | Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU) |
Shenzhen Ulike Smart Electronics Co.,Ltd. |
07/24/2025 | OHT |
| K250322 | Respond OC Conserving Regulator (130-0800) |
Responsive Respiratory | 07/24/2025 | NFB |
| K251455 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System |
Philips Ultrasound LLC | 07/24/2025 | IYN |
| K251618 | MOTO Partial Knee System Extension |
Medacta International S.A. |
07/24/2025 | HSX |
| K251968 | HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL |
Instrumentation Laboratory (IL) Co. |
07/24/2025 | KQJ |
| K251955 | Onflex™ Mesh | Davol Inc., Subsidiary of C. R. Bard, Inc. |
07/24/2025 | FTL |
| K243392 | Infusomat® Space Volumetric Infusion Pump Administration Sets |
B. Braun Medical Inc | 07/24/2025 | FPA |
| K252056 | Isolator® Synergy™ EnCompass Clamp And Guide System (OLH, OSH, GPM100) |
AtriCure, Inc. | 07/24/2025 | OCL |
| K251297 | MIS LYNX Conical Connection Implant System |
Dentsply Sirona Inc. | 07/24/2025 | DZE |
| K242615 | Intermittent Pressure Compression System (Compression Pump PT1005A; Leg Compression Cuffs; L-1001S, L-1001L, L-1001XL, L-1001XXL, L-1001XXXL) |
Xiamen Taotao Technology Co.,Ltd. |
07/23/2025 | IRP |
| K243373 | Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 Mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 Mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 Mm (REF 17502); EmbryoCath Stylet - 180 Mm (REF 17510); EmbryoCath Stylet - 230 Mm (REF 17511) |
Vitrolife Sweden AB | 07/23/2025 | MQF |
| K251280 | DESS® Dental Implants | Terrats Medical SL | 07/23/2025 | DZE |
| K250590 | MAGiC Sweep™ EP Mapping Catheter |
Stereotaxis, Inc. | 07/23/2025 | DRF |
| K243681 | Neuro Insight V1.0 | Olea Medical S.A.S. | 07/23/2025 | LLZ |
| K251265 | Resilience Fully Covered Esophageal Stent System |
Merit Medical Systems, Inc. |
07/23/2025 | ESW |
| K251213 | Da Vinci Surgical System (IS5000) |
Intuitive Surgical, Inc. | 07/23/2025 | NAY |
| K251073 | Innovasis Navigation Instruments (Vector G-E Navigation Instruments And The Excella G-E Navigation Instruments) |
Innovasis, Inc. | 07/23/2025 | OLO |
| K250716 | IMAGE ONE | Infomed Software, S.L. | 07/23/2025 | LLZ |
| K243781 | HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave Module (HEMVWM1); VitaWave Plus Finger Cuff (VWCA2) |
Edwards Lifesciences | 07/23/2025 | DQK |
| K251748 | MammoSTAR Biopsy Site Identifier |
Carbon Medical Technologies, Inc. |
07/23/2025 | NEU |
| K250280 | SD TL Implant System | ARUM DENTISTRY Co., Ltd. | 07/23/2025 | DZE |
| K244018 | Disposable Biopsy Needle | Zhejiang CuraWay Medical Technology Co., Ltd. |
07/22/2025 | KNW |
| K243425 | Guided DAS Surgical Kit | Talladium España, SL | 07/22/2025 | KCT |
| K251638 | Mobility Scooter (MS160C) | Suzhou Master Machinery Manufacturing Co., Ltd. |
07/22/2025 | INI |
| K243415 | Granudacyn® Wound Irrigation Solution |
P.G.F. Industry Solutions GmbH |
07/22/2025 | FRO |
| K251310 | OTS 25-L (100-5) | OTS Medical Ltd. | 07/22/2025 | MBI |
| K251616 | Clear Miracle | ODS Co., Ltd. | 07/22/2025 | NXC |
| K250686 | GyriCalc (Version 1.0.0) | NeuroSpectrum Insights Corp. |
07/22/2025 | LLZ |
| K243367 | Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle) |
Minnesota Medical Technologies |
07/22/2025 | PBP |
| K251255 | LymphaTech Mobile 3D Measuring Tool |
Lymphatech, Inc. | 07/22/2025 | SFG |
| K250211 | Yushan X-Ray Flat Panel Detector |
InnoCare Optoelectronics Corp. |
07/22/2025 | MQB |
| K243566 | CardioTag™ | Cardiosense, Inc. | 07/22/2025 | DXR |
| K250901 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 With AiCE Reconstruction Processing Unit For MR |
Canon Medical Systems Corporation |
07/22/2025 | LNH |
| K243432 | Vascular Navigation PAD 2.0; Navigation Software Vascular PAD |
Brainlab AG | 07/22/2025 | OWB |
| K251505 | VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) |
Alafair Biosciences | 07/22/2025 | JXI |
| K251300 | Plastic Surgical Kits | Dentsply Sirona, Inc. | 07/22/2025 | KCT |
| K251564 | Microinr System | iLine Microsystems S.L. | 07/21/2025 | GJS |
| K250913 | TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System |
Jiangsu Tingsn Technology Co., Ltd. |
07/19/2025 | OBJ |
| K251906 | Z1 Hip System | Zimmer, Inc. | 07/18/2025 | LZO |
| K250553 | Tomey Cornea/Anterior Segment OCT (CASIA2) |
TOMEY Corporation | 07/18/2025 | OBO |
| K243404 | HyHub™ And HyHub™ Duo Vial Access Devices |
Takeda Pharmaceuticals | 07/18/2025 | LHI |
| K252012 | SPY Cystoscope/Hysteroscope | Stryker Endoscopy | 07/18/2025 | HIH |
| K250999 | V8 Diagnostic Ultrasound System; Cv8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; Cv7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; Cv6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; Cv5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; Cv4 Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
07/18/2025 | IYN |
| K251542 | InstaFAN | OnePass Medical Ltd. | 07/18/2025 | ODG |
| K231562 | ELEC ENGINE (Model: ISE-170L) | Micro-NX Co., Ltd. | 07/18/2025 | EBW |
| K252218 | MF SC GEN2 Facial Toning System |
Micro Current Technology, Inc. |
07/18/2025 | NFO |
| K250902 | HeartFlow Analysis | HeartFlow, Inc. | 07/18/2025 | PJA |
| K243775 | True Non-Surgical Spinal Decompression System (DRX9000-SL) |
Excite Medical of Tampa Bay, LLC |
07/18/2025 | ITH |
| K250750 | INNOVISION-P5 | DK Medical Systems Co., Ltd |
07/18/2025 | IZL |
| K251585 | Profoject™ Enteral Feeding Syringe |
CMT Health PTE. Ltd. | 07/18/2025 | PNR |
| K250084 | MicroScan Dried Gram-Negative MIC/Combo Panels With Aztreonam (AZT) (0.5-64 Μg/ml) |
Beckman Coulter, Inc. | 07/18/2025 | LTT |
| K251809 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 07/18/2025 | MBI |
| K251655 | VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) |
Alafair Biosciences | 07/18/2025 | |
| K250952 | Baby Gorilla®/Gorilla® Plating System |
Paragon 28 Inc | 07/18/2025 | HRS |
| K250751 | DualView Catheter | Terumo Corporation | 07/17/2025 | DQO |
| K251839 | Umi Panvivo (uMI Panvivo); Umi Panvivo (uMI Panvivo S) |
Shanghai United Imaging Healthcare Co., Ltd. |
07/17/2025 | KPS |
| K243547 | Umr Ultra | Shanghai United Imaging Healthcare Co., Ltd. |
07/17/2025 | LNH |
| K242505 | Elecsys Cortisol III | Roche Diagnostics | 07/17/2025 | JFT |
| K251491 | K5 Cart, K5 Mount, K5 Swing | Osstem Implant Company., Ltd. Chair Business |
07/17/2025 | EIA |
| K251016 | MectaLIF 3D Metal | Medacta International S.A. |
07/17/2025 | MAX |
| K243324 | Masimo O3 Regional Oximeter | Masimo Corporation | 07/17/2025 | MUD |
| K243420 | HESTIA | GENORAY Co., Ltd. | 07/17/2025 | MUE |
| K251556 | Device 300423 Granules | Geistlich Pharma AG | 07/17/2025 | MQV |
| K243428 | E2coiltm Imaging System For The Siemens MAGNETOM 3.0T MRI Systems With Tim 4G Connector |
DxTx Medical, Inc. | 07/17/2025 | MOS |
| K243756 | 0.014” Willow Guidewire | Arbor Endovascular, LLC | 07/17/2025 | MOF |
| K251175 | VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201) |
Alafair Biosciences | 07/17/2025 | JXI |
| K251198 | HyperVue™ Software | SpectraWAVE, Inc. | 07/16/2025 | NQQ |
| K243397 | Umr 680 | Shanghai United Imaging Healthcare Co., Ltd. |
07/16/2025 | LNH |
| K243412 | ARCHIMEDES Biodegradable Pancreatic Stent |
Q3 Medical USA, LLC (c/o Q3 Medical Devices Ltd.) |
07/16/2025 | FGE |
| K250949 | Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) |
Olympus Medical Systems Corporation |
07/16/2025 | ODC |
| K251845 | Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus |
Kerecis Limited | 07/16/2025 | KGN |
| K251151 | Rapid CTA 360 | iSchemaView | 07/16/2025 | QAS |
| K251202 | Da Vinci Surgical System (IS5000) |
Intuitive Surgical, Inc. | 07/16/2025 | NAY |
| K251342 | EchoPAC Software Only / EchoPAC Plug-in |
GE Medical Systems Ultrasound and Primary Care Diagnostics |
07/16/2025 | QIH |
| K251102 | Automatic Blood Pressure Monitor (CH-S691L, CH-B607, CH-B606, CH-S692L, CH-S602, CH-W701L, CH-S693L, CH-B601L, CP-B01, CH-S603) |
Cemho Medical Technology (Guangdong) Co., Ltd. |
07/16/2025 | DXN |
| K243782 | StimTrial Neuromodulation System |
Bioventus LLC | 07/16/2025 | GZF |
| K242237 | Jewel Soft Tissue Reinforcement Device (102-6005) |
Xiros Limited | 07/15/2025 | |
| K251045 | Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U1683S-C51N); Disposable Neonatal NIBP Cuff (U1684S-C51N); Disposable Neonatal NIBP Cuff (U1685S-C51N) |
Unimed Medical Supplies, Inc. |
07/15/2025 | DXQ |
| K250119 | Tempus ECG-Low EF | Tempus AI, Inc. | 07/15/2025 | QYE |
| K250350 | Thrive 2-in-1 Breast Pump (Model P3) |
Shenzhen TPH Technology Co., Ltd. |
07/15/2025 | HGX |
| K250181 | AV Viewer | Philips Medical Systems Nederland B.V. |
07/15/2025 | LLZ |
| K251844 | Kerecis SurgiBind (50241) | Kerecis Limited | 07/15/2025 | OXH |
| K242818 | IsoSphere | IsoAid, LLC | 07/15/2025 | KXK |
| K251053 | Shinetell PlusTM Digital Early Pregnancy Test |
Hangzhou AllTest Biotech Co., Ltd. |
07/15/2025 | LCX |
| K251378 | CoolTone | Zimmer MedizinSysteme GmbH |
07/14/2025 | NGX |
| K250660 | LUMINOS Q.namix T; LUMINOS Q.namix R |
Siemens Medical Solutions |
07/14/2025 | OWB |
| K251173 | Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF) |
Shenzhen Fansizhe Science and Technology Co., Ltd. |
07/14/2025 | OHT |
| K251096 | PeekMed Web | Peek Health, S.A. | 07/14/2025 | QIH |
| K251850 | Phantom® Hindfoot TTC/TC Nail System |
Paragon 28, Inc | 07/14/2025 | HSB |
| K250120 | GECHO | Narnar, LLC | 07/14/2025 | LLZ |
| K251554 | Materialise TKA Guide System | Materialise N.V. | 07/14/2025 | JWH |
| K250185 | Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24) |
Jiangxi AICARE Medical Technology Co., Ltd. |
07/14/2025 | DXN |
| K243917 | F&P Optiflow Air/Oxygen Flow Source |
Fisher & Paykel Healthcare Ltd |
07/14/2025 | BZR |
| K251488 | FLOWRUNNER Aspiration System | Expanse Medical Inc. | 07/14/2025 | QEZ |
| K250504 | Leonardo Duster | CeramOptec GmbH | 07/14/2025 | GEX |
| K251132 | The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws |
Acumed LLC | 07/14/2025 | HRS |
| K243598 | Welch Allyn Connex® 360 (Multiple) |
Welch Allyn, Inc. | 07/13/2025 | |
| K243199 | NightWatch+ US | LivAssured BV | 07/12/2025 | POS |
| K241179 | Rhythm Express Remote Cardiac Monitoring System (RX-1 Mini) |
VivaQuant, Inc. | 07/11/2025 | QYX |
| K251134 | RipCord | TriMed, Inc. | 07/11/2025 | HTN |
| K250772 | Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter |
Surgical Instrument Service and Savings Inc. |
07/11/2025 | NLH |
| K243655 | TurbAlign | Spirair, Inc | 07/11/2025 | LYA |
| K250820 | Disposable Trocars | Sinolinks Medical Innovation, Inc. |
07/11/2025 | GCJ |
| K251470 | ResiCem EX | Shofu Dental Corporation | 07/11/2025 | EMA |
| K250942 | Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK) |
Shenzhen Ulike Smart Electronics Co., Ltd. |
07/11/2025 | OHT |
| K250761 | KALA Therapy Wand (Model: KALA-03) |
SHENZHEN KAIYAN MEDICAL EQUIPMENT CO., LTD |
07/11/2025 | OHS |
| K250034 | Natural Rubber Latex Male Condom |
Shaoguan Regenex Pharmaceuticals Co., Ltd. |
07/11/2025 | HIS |
| K251436 | Resolve Anterior Cervical Plate System |
Pioneer Surgical Technology, Inc |
07/11/2025 | KWQ |
| K251808 | Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia Elition S; Ingenia Elition X; Ingenia Ambition S; Ingenia Ambition X; And MR 5300 MR Systems |
Philips Medical Systems Nederland B.V. |
07/11/2025 | LNH |
| K250762 | ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R) |
Olympus Medical Systems Corporation |
07/11/2025 | ITX |
| K251482 | AEON™ Endoscopic Powered Stapler |
Lexington Medical, Inc. | 07/11/2025 | GAG |
| K251472 | Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System |
Inion Oy | 07/11/2025 | HBW |
| K251786 | Geistlich Bio-Oss®; Geistlich Bio-Oss Pen® |
Geistlich Pharma AG | 07/11/2025 | NPM |
| K251149 | AviClear Laser System | Cutera, Inc. | 07/11/2025 | GEX |
| K251352 | Codonics Safe Labeling System-Point Of Care Station (PCS) (SLS-700i And Related 610i, 620i, 630i Series Enabled To Retrofit RFID Features); Codonics Safe Labeling System-Point Of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration) |
Codonics.Incorporated | 07/11/2025 | BSZ |
| K250266 | Ceragem Automatic Thermal Massager (CGM MB-2401) |
CERAGEM Co, Ltd. | 07/11/2025 | JFB |
| K243274 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 And 2); And Influenza A/H5 Subtyping Kit (VER 4) |
Centers for Disease Control and Prevention |
07/11/2025 | OZE |
| K243296 | Disposable Biopsy Needle | Carbon (Shenzhen) Medical Device Co., Ltd. |
07/11/2025 | KNW |
| K250671 | FreeStyle Comfort (AS200 / FreeStyle Comfort) |
CAIRE Inc. | 07/11/2025 | CAW |
| K250156 | Choice 2 DC | Bisco, Inc | 07/11/2025 | EMA |
| K251155 | BD Cathena™ Safety IV Catheter |
Becton Dickinson Infusion Therapy Systems Inc. |
07/11/2025 | FOZ |
| K243227 | B-Scan | ACCUTOME, INC. Doing Business As Keeler USA |
07/11/2025 | IYO |
| K243252 | ZBPro Diagnostic | ZBeats Inc. | 07/10/2025 | DPS |
| K251945 | TriMed Total Wrist Fusion System (Total Wrist Fusion Plate) |
TriMed, Inc. | 07/10/2025 | HRS |
| K244004 | Microcurrent Facial Device (CEC101, EE0101, EEI101) |
Shenzhen Dachi communication Co.,Ltd. |
07/10/2025 | NFO |
| K251885 | CAVUX Facet Fixation System (CAVUX FFS) And CORUS-LX Implant |
Providence Medical Technology, Inc. |
07/10/2025 | MRW |
| K250283 | RAP Femoral Venous Cannulae | LivaNova USA inc | 07/10/2025 | DWF |
| K251169 | Vivid Pioneer | GE Medical Systems Ultrasound and Primary Care Diagnostics |
07/10/2025 | IYN |
| K251830 | Sonosite LX Ultrasound System | FUJIFILM Sonosite, Inc. | 07/10/2025 | IYN |
| K250032 | Marquee™ Disposable Core Biopsy Instrument And Instrument Kit |
Bard Peripheral Vascular, Inc. |
07/10/2025 | KNW |
| K250072 | CONDUIT™ SYNFIX™ Evolution Secured Spacer System |
Avalign Technologies, Inc. |
07/10/2025 | OVD |
| K250063 | ARENA Star, Galaxy Star | ARUM Dentistry Co., Ltd. | 07/10/2025 | EIH |
| K251145 | Arthrex PushLock Suture Anchors |
Arthrex Inc. | 07/10/2025 | MBI |
| K250247 | Panasia SI Fusion System | Wenzel Spine, Inc. | 07/09/2025 | OUR |
| K251520 | Cios Alpha; Cios Flow | Siemens Medical Solutions USA, Inc |
07/09/2025 | OWB |
| K250505 | EZ-FIDUCIALS | Phasor Health, LLC | 07/09/2025 | HAW |
| K243731 | HEXIM Implant; Samwon General Abutments |
P&A USA | 07/09/2025 | DZE |
| K250133 | HARBOR Occlusion Device | Nuvascular Inc. | 07/09/2025 | KRD |
| K250108 | OptiVu™ Shoulder | MR Surgical Solutions, LLC |
07/09/2025 | SBF |
| K242562 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P |
GE Medical Systems Information Technologies, Inc. |
07/09/2025 | MHX |
| K251759 | Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers |
Boston Scientific Corporation |
07/09/2025 | GEX |
| K250193 | Nitrile Powder-Free Exam Gloves 2.8, Tested For Use With Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light Blue, Dark Blue) |
Basic Medical Technology Inc. |
07/09/2025 | LZA |
| K243500 | ARCHITECT Igentamicin | Abbott Laboratories | 07/09/2025 | LCD |
| K251447 | K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) |
Terumo Europe N.V. | 07/08/2025 | FMI |
| K240908 | Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) |
Spectrum Medical Ltd. | 07/08/2025 | DTR |
| K251766 | TumorSight Viz | SimBioSys, Inc. | 07/08/2025 | QIH |
| K250695 | Single-use Ureteral Access Sheath |
Shenzhen HugeMed Medical Technical Development Co., Ltd. |
07/08/2025 | FED |
| K251804 | KHEIRON® Spinal Fixation System, Including Patient Specific K-ROD |
S.M.A.I.O | 07/08/2025 | NKB |
| K251761 | Anovo Surgical System (Model 6Ne); Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode |
Momentis Surgical Ltd. | 07/08/2025 | QNM |
| K251741 | PathLoc Lumbar Interbody Fusion Cage System |
L&K BIOMED Co., Ltd. | 07/08/2025 | MAX |
| K250065 | DENSITY; DENZA; DENSITY Noir | Jeisys Medical Incorporated |
07/08/2025 | GEI |
| K241525 | ExcelsiusXR™ | Globus Medical, Inc. | 07/08/2025 | SBF |
| K251776 | EMPOWR Revision Knee™ (EMPOWR Revision VVC+, E+ Tibial Insert) |
Encore Medical, L.P. | 07/08/2025 | JWH |
| K250342 | Powder-Free Polychloroprene Examination Glove (Green Color) Tested For Use With Chemotherapy Drugs And Fentanyl |
Encompass Industries Sdn. Bhd. |
07/08/2025 | LZA |
| K250496 | Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White) |
Zibo Shengkun Chemical Industry Co., Ltd |
07/07/2025 | LZA |
| K251502 | TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System |
Life Spine, Inc. | 07/07/2025 | MAX |
| K251863 | CustomSurg OrthoPlanner | CustomSurg AG | 07/07/2025 | LLZ |
| K250827 | Aprevo® Anterior Lumbar Interbody Fusion Device; Aprevo® Lateral Lumbar Interbody Fusion Device; Aprevo® Anterior Lumbar Interbody Fusion Device With Interfixation; Aprevo® Transforaminal Lumbar Interbody Fusion Device; Aprevo® TLIF-CA Articulating System; Aprevo® Cervical ACDF; Aprevo® Cervical ACDF-X; Aprevo® Cervical ACDF-X No Cams |
Carlsmed, Inc. | 07/07/2025 | MAX |
| K243884 | TAVIPILOT | Caranx Medical | 07/07/2025 | OWB |
| K250165 | Pastelle | WONTECH Co., Ltd. | 07/03/2025 | GEX |
| K243280 | Piezomed Pro (Piezomed Pro Module M-PM100 Incl. Handpiece M-PH350, Piezomed Pro Instruments (various Tips) And Accessories) |
W&H Dentalwerk Buermoos GmbH |
07/03/2025 | ERL |
| K251390 | MTA Vpt | VOCO GmbH | 07/03/2025 | KIF |
| K243255 | URIS Long Implant & Abutments | TruAbutment Inc. | 07/03/2025 | DZE |
| K243679 | MammoScreen® (4) | Therapixel | 07/03/2025 | QDQ |
| K250286 | Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1) |
The Magstim Company Limited |
07/03/2025 | QPL |
| K251054 | Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips |
Teleflex Medical | 07/03/2025 | FZP |
| K251528 | Syngo.via MI Workflows; Scenium; Syngo MBF |
Siemens Medical Solutions USA, Inc. |
07/03/2025 | QIH |
| K250822 | SOMATOM Go.now; SOMATOM Go.up; SOMATOM Go.all; SOMATOM Go.top; SOMATOM Go.sim; SOMATOM Go.open Pro; SOMATOM Pro.Pulse |
Siemens Medical Solutions USA, Inc. |
07/03/2025 | JAK |
| K250448 | Disposable Percutaneous Nephrostomy Dilatation Kit |
Shenzhen Trious Medical Technology Co., Ltd |
07/03/2025 | LJE |
| K243220 | Onera STS 2 (ONERA STS 2) | Onera B.V. | 07/03/2025 | MNR |
| K243123 | IPL Treatment Device (MDSQMC-01) |
Medusa (Guangxi)Medical Devices Co., Ltd. |
07/03/2025 | ONF |
| K243826 | SMR Reverse HP Shoulder System | LimaCorporate S.p.A. | 07/03/2025 | PHX |
| K250398 | Innovita Flu A/B Antigen Rapid Test |
Innovita (Tangshan) Biological Technology CO., LTD |
07/03/2025 | PSZ |
| K251599 | Single-use Ureteral Access Sheath |
Hunan Vathin Medical Instrument Co., Ltd. |
07/03/2025 | FED |
| K250838 | Denudation Pipettes | Guangzhou PINZHI Medical Device Co., Ltd. |
07/03/2025 | MQH |
| K251291 | Advanix™ Pancreatic Stent And NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System And Pushers |
Boston Scientific | 07/03/2025 | FGE |
| K243678 | TalisMann Neuromodulation System |
Bioventus LLC | 07/03/2025 | GZF |
| K250733 | 3DOSE 1ml Syringe | Bimed Teknik Aletler Sanayi & Ticaret A.S. |
07/03/2025 | FMF |
| K243207 | BD Vacutainer® Eclipse™ Blood Collection Needle |
Becton Dickinson and Company |
07/03/2025 | JKA |
| K250105 | Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125) |
Aveera Medical, Inc. | 07/03/2025 | MGZ |
| K251080 | IdentiTi II Cervical Interbody System |
Alphatec Spine, Inc. | 07/03/2025 | ODP |
| K251671 | Biograph Vision PET/CT Systems; Biograph Mct PET/CT Systems |
Siemens Medical Solutions USA, Inc. |
07/03/2025 | KPS |
| K250848 | Identity Shoulder System | Zimmer Inc. | 07/02/2025 | MBF |
| K250587 | Orthoscan TAU Mini C-Arm | Ziehm-Orthoscan, Inc. | 07/02/2025 | OXO |
| K251285 | Electric Wheelchair (HG-630) | Zhejiang Automwheel Tech Co., Ltd. |
07/02/2025 | ITI |
| K250729 | Power Wheelchair (MOB1107) | Vive Health LLC | 07/02/2025 | ITI |
| K250684 | OPUSWAVE Dual Sensor Imaging System |
Terumo Cardiovascular Systems THI Plant |
07/02/2025 | NQQ |
| K251746 | Pure Impact | Sofwave Medical Ltd. | 07/02/2025 | NGX |
| K251031 | Fiber Laser Treatment Systems (HS-232,HS-233) |
Shanghai Apolo Medical Technology Co., Ltd. |
07/02/2025 | ONG |
| K243868 | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses |
Pegavision Corporation | 07/02/2025 | LPL |
| K243701 | AuroLase® System | Nanospectra Biosciences, Inc. |
07/02/2025 | GEX |
| K251049 | SurgiLight 1470 Diode Laser System (Model:Halo) |
Micro-Energy Medical Technology Co., Ltd |
07/02/2025 | GEX |
| K250524 | Mendaera Guidance System | Mendaera, Inc. | 07/02/2025 | ITX |
| K250312 | Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus And Soft Plus Cannula Extra Small |
Medline Industries, LP. | 07/02/2025 | BTT |
| K243468 | Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103) |
JOYTECH Healthcare Co., Ltd. |
07/02/2025 | CAF |
| K251490 | 8 Mm Assist Cannula; 12 Mm Assist Cannula |
Intuitive Surgical, Inc. | 07/02/2025 | GCJ |
| K251241 | EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones) |
Encore Medical, L.P. | 07/02/2025 | JWH |
| K250391 | Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™) |
Elekta Solutions AB | 07/02/2025 | IWB |
| K250779 | CS-Pro MED | Curative Sound Therapeutics |
07/02/2025 | PZL |
| K243399 | Boehringer Laboratories Liver Retractor |
Boehringer Laboratories, LLC |
07/02/2025 | GCJ |
| K250279 | RC-SwiftPrep | Belport Company, Inc., Gingi-Pak |
07/02/2025 | KJJ |
| K250415 | G0 Blood Pressure Monitoring System (G0) |
Aktiia SA | 07/02/2025 | DXN |
| K251720 | OsteoFlo HydroFiber | SurGenTec, LLC | 07/02/2025 | MQV |
| K251719 | Momentum® Posterior Spinal Fixation System |
Ulrich Medical USA, Inc. | 07/01/2025 | NKB |
| K250204 | Endoscopic Camera System | Shenzhen Sophway Technology Co., Ltd. |
07/01/2025 | FET |
| K243690 | SonoMSK | PAJUNK GmbH Medizintechnologie |
07/01/2025 | BSP |
| K251032 | MiniMed 780G Insulin Pump | Medtronic MiniMed Inc. | 07/01/2025 | QFG |
| K251933 | SnugFit ASA Extension | Medacta International S.A. |
07/01/2025 | MBI |
| K250016 | Droplet® Personal Lancets | HTL-Strefa S.A. | 07/01/2025 | QRK |
| K250096 | Felix NeuroAI System | Fasikl Incorporated | 07/01/2025 | QBC |
| K250699 | Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit With Supplies (T8K); Cure Twist Female 10 Catheter Kit With Supplies (T10K); Cure Twist Female 12 Catheter Kit With Supplies (T12K); Cure Twist Female 14 Catheter Kit With Supplies (T14K); Cure Twist Female 16 Catheter Kit With Supplies (T16K) |
Convatec | 07/01/2025 | EZD |
| K250221 | StrokeSENS ASPECTS Software Application |
Circle Cardiovascular Imaging Inc. |
07/01/2025 | POK |
| K243779 | Bunkerhill Abdominal Aortic Quantification (AAQ) |
BunkerHill Health | 07/01/2025 | QIH |
| K251453 | Arthrex Ibalance Partial Knee System |
Arthrex Inc. | 07/01/2025 | HSX |
| K251212 | Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM) |
Access Vascular, Inc. | 07/01/2025 | LJS |
| K243485 | Alinity M CMV | Abbott Molecular Inc. | 07/01/2025 | PAB |
| K250987 | Aprevo® Posterior/transforaminal Lumbar Interbody Fusion Device |
Carlsmed Inc. | 06/30/2025 | MAX |
| K243647 | Synapse PACS (7.5) | FUJIFILM Healthcare Americas Corporation |
06/30/2025 | QIH |
| K250670 | EchoConfidence (USA) | Mycardium AI Limited | 06/30/2025 | QIH |
| K251088 | Otsuka Digital Feedback Device | Otsuka America Pharmaceutical, Inc. |
06/30/2025 | OZW |
| K250484 | PIUR Tus Inside | PIUR Imaging GmbH | 06/30/2025 | QIH |
| K251000 | Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09) |
Shenzhen Chuangtong Yigou Technology Co., Ltd |
06/30/2025 | OHT |
| K250990 | The Sensititre 18-24 Hour MIC Or Breakpoint Susceptibility System With Ciprofloxacin In The Dilution Range Of 0.002-64 Ug/ml |
Thermofisher Scientific | 06/30/2025 | JWY |
| K250022 | HeroTracker Sense | Voluntis | 06/30/2025 | CAF |
| K250972 | Primum Hydrophilic Guiding Catheter |
PendraCare | 06/29/2025 | DQY |
| K251654 | BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter And BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter |
Becton Dickinson Infusion Therapy Systems Inc. |
06/27/2025 | FOZ |
| K251660 | T3 Pro Implants– ZimVie Packaging System |
Biomet 3i, LLC | 06/27/2025 | DZE |
| K250310 | VIKING™ Fixed Curve Diagnostic Catheter |
Boston Scientific Corporation |
06/27/2025 | DRF |
| K250585 | LumenaTM Ureteral Access Sheath |
CatheGenix (Xiamen) Co., Ltd. |
06/27/2025 | FED |
| K250828 | CPS Locator 3D Plus Delivery Catheter |
CenterPoint Systems LLC | 06/27/2025 | DQY |
| K251116 | Luja Coudé | Coloplast Corp. | 06/27/2025 | EZD |
| K243187 | Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) |
Cork Medical | 06/27/2025 | OMP |
| K250969 | JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST |
Dent4You AG | 06/27/2025 | ELW |
| K243077 | Affirm 800 | Digital Surgery Systems, Inc. (d.b.a True Digital Surgery) |
06/27/2025 | IZI |
| K243900 | Emotus Respiratory Motion Management System |
EmpNia Inc. | 06/27/2025 | LHN |
| K242988 | Genostis Osteosynthesis System | Genostis AF | 06/27/2025 | HRS |
| K243130 | Integral Dental Unit | GUANGDONG YADENG MEDICAL APPARATUS CO., LTD., |
06/27/2025 | EIA |
| K251431 | FIX-C PEEK ACIF SA System | Jeil Medical Corporation | 06/27/2025 | OVE |
| K250610 | Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) |
Livanova USA Inc | 06/27/2025 | DWF |
| K243388 | Disposable Distal Cap | Micro-Tech (Nanjing) Co., Ltd. |
06/27/2025 | FDS |
| K250984 | Maestro System (REF100) | Moon Surgical | 06/27/2025 | QZB |
| K250522 | Multi4 System | Multi4 Medical AB | 06/27/2025 | FAS |
| K251210 | Ampa One System (AMPA-001) | Neuromodulatory Devices & Applications |
06/27/2025 | OBP |
| K243682 | SonoPlex STIM; SonoPlex II | PAJUNK GmbH Medizintechnologie |
06/27/2025 | BSP |
| K250648 | Philips Ict CT System | Philips Medical Systems Nederland B.V. |
06/27/2025 | JAK |
| K251329 | Diode Laser Device (RF3120-BI) | RiSu Medical Technology Co., Ltd. |
06/27/2025 | GEX |
| K243183 | RTM Sense (A-0001) | RTM Vital Signs, LLC | 06/27/2025 | BZQ |
| K243144 | X100/X100HT With Full Field Peripheral Blood Smear (PBS) Application |
Scopio Labs Ltd. | 06/27/2025 | JOY |
| K243816 | Testa TP Pivoting Spacer System |
Spine Wave, Inc. | 06/27/2025 | MAX |
| K243190 | USTOMED Bone Fixation/Bone Augmentation Systems - PIN |
Ustomed Instrumente Ulrich Storz GmbH & Co. KG |
06/27/2025 | DZL |
| K251642 | Dental CBCT X-ray System | Yian Medical Technology (Haining) Co., Ltd. |
06/27/2025 | OAS |
| K250940 | Atmo Gas Capsule System | Atmo Biosciences Ltd | 06/26/2025 | NYV |
| K243175 | Disposable Intermittent Catheter (TPU Catheter) |
Chengdu Daxan Innovative Medical Tech. Co., Ltd |
06/26/2025 | |
| K243275 | Equinoxe® Scapula Fracture System |
Exactech, Inc | 06/26/2025 | HRS |
| K251613 | SwissGraft X | Geistlich Pharma AG | 06/26/2025 | NPM |
