IFU is not found for this 510(k).
| 510(k) Number | Device Name | Applicant | Decision Date | Procode |
|---|
510(k) Number | Device Name | Applicant | Decision Date | Procode |
|---|---|---|---|---|
| K251071 | Fetal EchoScan (v1.1) | BrightHeart | 05/02/2025 | POK |
| K251056 | Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode |
Momentis Surgical Ltd. | 05/02/2025 | QNM |
| K251048 | Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 |
STERIS Corporation | 05/02/2025 | JOJ |
| K250629 | Sutil Rich Personal Lubricant | Hathor Professional Skincare Ltd. |
05/02/2025 | NUC |
| K250292 | OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) |
SkyDance Vascular, Inc. | 05/02/2025 | FOZ |
| K250161 | Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B); Wrist Blood Pressure Monitor (AOJ-35D); Wrist Blood Pressure Monitor (AOJ-35E); Wrist Blood Pressure Monitor (AOJ-35F); Wrist Blood Pressure Monitor (AOJ-35G); Wrist Blood Pressure Monitor (WRS-35G); Wrist Blood Pressure Monitor (WRS-35H); Wrist Blood Pressure Monitor (WRS-35K); Wrist Blood Pressure Monitor (WRS-35N); Wrist Blood Pressure Monitor (WRS-35P); Wrist Bloo |
Shenzhen AOJ Medical Technology Co., Ltd. |
05/02/2025 | DXN |
| K244014 | I-stat CG4+ Cartridge With The I-stat 1 System |
Abbott Point of Care Inc. |
05/02/2025 | CHL |
| K244001 | KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2) |
KARL STORZ SE & CO. KG | 05/02/2025 | FBO |
| K243894 | F88 URE-SD/RD Flexible Ureteroscope |
SG Endoscopy Pte Ltd | 05/02/2025 | FGB |
| K243828 | CIONIC NEURAL SLEEVE (NS-200) | CIONIC Inc. | 05/02/2025 | GZI |
| K243757 | Shockwave CS Guide Catheter | Shockwave Medical, Inc. | 05/02/2025 | DQY |
| K243457 | Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel |
Seriously Clean, Ltd | 05/02/2025 | FRO |
| K243114 | SQA-iOw Sperm Quality Analyzer | Medical Electronic Systems Ltd. |
05/02/2025 | POV |
| K243069 | LUMYS (V1) | INTRADYS | 05/02/2025 | LLZ |
| K243043 | Origin™ Cemented Hip Stem | Signature Orthopaedics Pty Ltd |
05/02/2025 | LZO |
| K242986 | SpO2 Extension Cable | Beijing Rongrui-Century Science & Technology Co., Ltd. |
05/02/2025 | DSA |
| K242763 | JetCan® Pro Safety Huber Needle |
PFM Medical, Inc | 05/02/2025 | FPA |
| K242583 | AT-Patch (ATP-C130/ATP-C70) | ATsens Co.,Ltd. | 05/02/2025 | DSH |
| K251014 | APRO 45 Catheter | Alembic, LLC | 05/01/2025 | DQY |
| K251007 | CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) |
Circa Scientific, Inc. | 05/01/2025 | DXF |
| K250996 | Xpert Xpress CoV-2/Flu/RSV Plus |
Cepheid® | 05/01/2025 | QOF |
| K250995 | Xpert Xpress CoV-2/Flu/RSV Plus |
Cepheid® | 05/01/2025 | QOF |
| K250641 | APEX 3D Total Ankle Replacement System |
Paragon 28, Inc. | 05/01/2025 | HSN |
| K250296 | Disposable Distal Attachment D-201 Series |
Olympus Medical Systems Corp. |
05/01/2025 | FDS |
| K250087 | Vscan Air | GE Medical Systems Ultrasound and Primary Care Diagnostics |
05/01/2025 | IYN |
| K250029 | ONE TRAY® Sealed Sterilization Container System |
Innovative Sterilization Technologies |
05/01/2025 | KCT |
| K244020 | Wrinkle Treatment Device (JM1, JM2B) |
Shenzhen Qianyu Technology Co., Ltd. |
05/01/2025 | OHS |
| K243870 | X°Port Lung Preservation System; X°Port Lung Preservation Solution |
Traferox Technologies Inc. |
05/01/2025 | KDN |
| K243521 | Conical Ti Base Abutments | BioHorizons Implant Systems Inc. |
05/01/2025 | NHA |
| K242315 | Resolve Modular Revision Hip Stem |
United Orthopedic Corporation |
05/01/2025 | MEH |
| K251051 | AuST Steerable Sheath | CenterPoint Systems LLC | 04/30/2025 | DYB |
| K251024 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge |
Haemonetics | 04/30/2025 | JPA |
| K251015 | APRO 45 Catheter And Alembic Aspiration Tubing |
Alembic, LLC | 04/30/2025 | NRY |
| K250907 | Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set |
Sol-Millennium Medical, Inc. |
04/30/2025 | JKA |
| K250683 | Resolve Fundus Camera | Optain Health, Inc. | 04/30/2025 | HKI |
| K250497 | Additive Manufacturing (Light Curing) Crown Bridge Resin |
Aidite (Qinhuangdao) Technology Co., Ltd |
04/30/2025 | EBF |
| K250328 | UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program |
Canon Medical Systems Corporation |
04/30/2025 | |
| K250295 | Dentsply Sirona Titanium Bases System |
Dentsply Sirona | 04/30/2025 | NHA |
| K250282 | Persona C HR | A.T.S. Applicazione Tecnologie Speciali s.r.l. |
04/30/2025 | OWB |
| K250274 | ETEST Imipenem/Relebactam P. Aeruginosa (IRPA) (0.008/4-128/4 Μg/ml) |
bioMerieux, SA | 04/30/2025 | JWY |
| K244000 | Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood Pressure Monitor (ARM-30Q);Arm Blood Pressure Monitor (ARM-30E+); |
Shenzhen AOJ Medical Technology Co., LTD |
04/30/2025 | DXN |
| K243942 | Arctic Sun Stat Temperature Management System |
Medivance, Inc. | 04/30/2025 | DWJ |
| K243934 | Stable-L Lumbar Interbody System |
Nexus Spine, LLC | 04/30/2025 | OVD |
| K243541 | LumiRex Bronchoscope | Contra Healthcare Solutions, LLC |
04/30/2025 | EOQ |
| K250962 | APRO 55 Intermediate Catheter | Alembic, LLC | 04/29/2025 | DQY |
| K250617 | Apex Flex | SprintRay Inc. | 04/29/2025 | EBI |
| K250308 | Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S) |
Dongguan Boyuan Intelligent Technology Co., Ltd. |
04/29/2025 | OAP |
| K250069 | Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile And Protein Claim Of 50 Micrograms Per Dm2 Or Less Protein |
Comfort Rubber Gloves Industries Sdn. Bhd. |
04/29/2025 | LYY |
| K243963 | Pediatric Plating Platform Hip | OrthoPediatrics Corp. | 04/29/2025 | HRS |
| K243886 | ExpressCore Biopsy Device | INRAD, Inc | 04/29/2025 | KNW |
| K242495 | LMA Fastrach ETT SU | Teleflex Medical | 04/29/2025 | BTR |
| K242354 | AllNEB | Enchant Tek Co. Ltd. | 04/29/2025 | CAF |
| K242255 | Qitexio® 4-Way Stopcock (QIT014) |
Medex | 04/29/2025 | FMG |
| K242211 | PUMA-G Pediatric System | CoapTech Inc. | 04/29/2025 | KGC |
| K250977 | Suture-TOOL System | Suturion AB | 04/28/2025 | NEW |
| K250958 | APRO 55 Swift Catheter And Alembic Aspiration Tubing |
Alembic, LLC | 04/28/2025 | NRY |
| K250256 | Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) And Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000)) |
AventaMed DAC | 04/28/2025 | ETD |
| K250158 | Electric Wheelchair (ZH-W001,ZH-W002 ,ZH-W003) |
Zhe jiang Cleisman Industry and Trade Co.,LTD |
04/28/2025 | ITI |
| K250030 | Flash Ultrasound System 5100 Point Of Care |
Philips Ultrasound LLC | 04/28/2025 | IYN |
| K243896 | LenSx Laser System (8065998162) |
Alcon Laboratories, Inc. | 04/28/2025 | OOE |
| K243532 | LumiRex Ureteroscope | Contra Healthcare Solutions, LLC |
04/28/2025 | FGB |
| K243376 | Uangio AVIVA CX | Shanghai United Imaging Healthcare Co.,Ltd. |
04/28/2025 | OWB |
| K242951 | Diode Laser Hair Removal Machine (QDTM-02) |
Beijing Nubway S&T Co., Ltd. |
04/28/2025 | GEX |
| K241663 | Eminent Spine 3D Titanium Pedicle Screw System |
Eminent Spine | 04/28/2025 | NKB |
| K251101 | AIRO Suction Unit (AIRO-01) | CRO, LLC | 04/26/2025 | BTA |
| K251117 | Cervical Spine Truss System (CSTS) |
4WEB Medical | 04/25/2025 | OVE |
| K251075 | DYNAMIS™ Implant System | Promethean Restorative LLC |
04/25/2025 | OUR |
| K250909 | Prelude Wave Hydrophilic Sheath Introducer |
Merit Medical Systems, Inc. |
04/25/2025 | DYB |
| K250892 | CastleLoc Pectus Bar System | L&K Biomed Co., Ltd. | 04/25/2025 | HRS |
| K250723 | FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration) |
Cardio Flow Inc. | 04/25/2025 | MCW |
| K250608 | Mako Total Knee Application (3.0); Hybrid Tip Pointer |
Mako Surgical Corp. | 04/25/2025 | OLO |
| K250554 | Prodisc® L Instruments | Centinel Spine LLC | 04/25/2025 | QLQ |
| K250426 | Amulet™ Steerable Delivery Sheath |
Abbott Medical | 04/25/2025 | DQY |
| K250289 | Intracavitary/Interstitial System |
Varian Medical Systems | 04/25/2025 | JAQ |
| K250153 | Neu Platform | Neuhealth Digital Ltd. | 04/25/2025 | GYD |
| K250046 | Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617) |
Shenzhen Urion Technology Co., Ltd. |
04/25/2025 | IRP |
| K244026 | PAL 7020 Console | MicroAire Surgical Instruments, LLC |
04/25/2025 | QPB |
| K243998 | DCX Disposable Cassette (DCX) | Institut Geroges Lopez | 04/25/2025 | KDN |
| K243876 | VERIFY STEAM Integrating Indicator |
STERIS Corporation | 04/25/2025 | JOJ |
| K243861 | Butterflybvm | Compact Medical, Inc. | 04/25/2025 | BTM |
| K243855 | BD Alaris Infusion System With Guardrails Suite MX |
CareFusion 303, Inc. | 04/25/2025 | FRN |
| K243821 | I-cut | A.M.I. Agency for Medical Innovations GmbH |
04/25/2025 | HET |
| K243721 | Self Sealing Sterilization Pouches |
Wellmed Dental Medical Supply Co., Ltd |
04/25/2025 | FRG |
| K243570 | Dimension LOCI Thyroid Stimulating Hormone Flex Reagent Cartridge (TSHL); Dimension LOCI Free Thyroxine Flex Reagent Cartridge (FT4L) |
Siemens Healthcare Diagnostics |
04/25/2025 | JLW |
| K243406 | Cobas Liat SARS-CoV-2, Influenza A/B & RSV Nucleic Acid Test |
Roche Molecular Systems, Inc. |
04/25/2025 | QOF |
| K243400 | Cobas Liat SARS-CoV-2 & Influenza A/B V2 Nucleic Acid Test |
Roche Molecular Systems, Inc. |
04/25/2025 | QOF |
| K243264 | DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14) |
Sorin Group Italia S.r.l. |
04/25/2025 | KDI |
| K243082 | Infrared Thermometer | Guangzhou Daxin Health Technology Co., Ltd |
04/25/2025 | FLL |
| K243041 | Contact Forte Alpha | BHM-Tech Produktionsgesellschaft mbH |
04/25/2025 | LXB |
| K242469 | RFMagik Lite | Agnes Medical Co., Ltd | 04/25/2025 | GEI |
| K242321 | Kosmos | EchoNous, Inc. | 04/25/2025 | IYN |
| K250262 | GO-PEN® | GO-Pen ApS | 04/24/2025 | FMF |
| K250206 | Diode Laser System (Night Universe; Predator) |
Ivylaser (Beijing) Technology Co.,Ltd |
04/24/2025 | GEX |
| K250183 | CO2 Laser System (CO2 Laser SST-L23) |
Zhuozhou Summer Star Technologies Co., Ltd |
04/24/2025 | GEX |
| K250116 | Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure Monitor (ARM-30K); Arm Blood Pressure Monitor (ARM-90B) |
Shenzhen AOJ Medical Technology Co., Ltd |
04/24/2025 | DXN |
| K250002 | Smart Check O2 (MA0236) | Life Spark Medical, LLC | 04/24/2025 | CCL |
| K243954 | PeriCross™ Epicardial Access Kit |
CIRCA Scientific, Inc. | 04/24/2025 | DYB |
| K243945 | ALARA BMA Neuro Access Kit (ALARA BMAN And ALARA BMAC Kit) |
SurGenTec LLC | 04/24/2025 | KNW |
| K243714 | Da Vinci SP Surgical System (SP1098) |
Intuitive Surgical, Inc. | 04/24/2025 | NAY |
| K243239 | Lung AI (LAI001) | Exo Inc | 04/24/2025 | MYN |
| K242973 | CanMINI Hand And Foot System | CANWELL MEDICAL CO., LTD. |
04/24/2025 | HRS |
| K242963 | MENTOR™ PliaForm™ Breast Tissue Expander W/ Suture Tabs |
Mentor Worldwide LLC | 04/24/2025 | LCJ |
| K242514 | Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) |
Shenzhen Rogin Medical Co., Ltd. |
04/24/2025 | EKX |
| K242214 | Sonu | Sound Health Systems, Inc. |
04/24/2025 | QZC |
| K233337 | Freespira Breathing System | Freespira, Inc | 04/24/2025 | SEN |
| K250944 | Nitrile Powder Free Examination Glove, Blue Tested For Use With 60 Chemotherapy Drugs, Gastric Acid, Xylazine And Fentanyl |
GMP Medicare Sdn. Bhd. | 04/23/2025 | LZA |
| K250869 | Parietene™ Macroporous Mesh (PPM5050 ) |
Sofradim Production | 04/23/2025 | FTL |
| K250831 | Annalise Enterprise | Annalise-AI | 04/23/2025 | QFM |
| K250697 | Electric Nasal Aspirator (BC026, BC025, BC023) |
Shenzhen Kingboom Technology Co., Ltd |
04/23/2025 | BTA |
| K250228 | Ehertz Functional Series Diagnostic Ultrasound System (eHertz C, Ehertz E, Ehertz R, Ehertz S) |
eSonic Technology (Wuhan) Co., LTD |
04/23/2025 | IYN |
| K250198 | Laon Ortho | LAON MEDI Inc. | 04/23/2025 | PNN |
| K250155 | Xpert Knee | Newclip Technics | 04/23/2025 | HRS |
| K243697 | MySpine WebPlanner | Medacta International S.A. |
04/23/2025 | LLZ |
| K243479 | EchoGuide (Version 1) | Sonavex, Inc. | 04/23/2025 | IYO |
| K243326 | Dynamis Robotic Surgical System |
LEM Surgical AG | 04/23/2025 | OLO |
| K242531 | NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum Halepense); Capture Reagent T007, Oak (Quercus Alba) ; Capture Reagent G002, Bermuda Grass (Cynodon Dactylon); Capture Reagent W001, Common Ragweed (Ambrosia Artemisiifolia); Capture Reagent E005, Dog Dander (Canis Familiaris); Capture Reagent T003, Common Silver Birch (Betula Verrucosa); Capture Reagent F001, Egg White (Gallus Gallus); Capture Reagent F002, Cow's Milk (Bos Taurus); NOVEOS Immunoassay Analyz |
Hycor Biomedical | 04/23/2025 | DHB |
| K242232 | Mpact 3D Metal Augments II | Medacta International S.A. |
04/23/2025 | LPH |
| K250669 | Adaptix™ Interbody System With Titan Nanolock™ Surface Technology |
Medtronic Sofamor Danek, USA Inc. |
04/22/2025 | MAX |
| K243944 | Aperta NSE PTA Balloon Dilatation Catheter |
Goodman Co., Ltd. | 04/22/2025 | PNO |
| K243621 | Evoblock, Perléon | Evoden Indústria Comércio Importação e Exportação |
04/22/2025 | EBG |
| K243386 | Ventris Intervertebral Body Fusion Device |
Acuity Surgical Devices LLC |
04/22/2025 | OVD |
| K243343 | BD CTGCTV2 | BD Integrated Diagnostic Solutions/Becton, |
04/22/2025 | QEP |
| K242542 | Medentika CAD/CAM Abutments | Medentika GmbH | 04/22/2025 | NHA |
| K242247 | ARIX Femur Nail System | Jeil Medical Corporation | 04/22/2025 | HSB |
| K241931 | OcuMet Beacon (OCUB100) | OcuSciences, Inc. | 04/22/2025 | MYC |
| K251196 | Composite Orthodontic Brackets And Buttons |
EC Certification Service GmbH |
04/21/2025 | DYW |
| K250176 | DAND Dental Implant System | D.A.N.D. Metal Industries North Ltd |
04/21/2025 | DZE |
| K243875 | Spectricept Skin And Wound Cleanser |
Spectrum Antimicrobials, Inc. |
04/21/2025 | FRO |
| K243651 | VersaViewer | GE Medical Systems SCS | 04/21/2025 | LLZ |
| K243508 | Wearable Breast Pump (model S12A) |
Shenzhen TPH Technology Co., Ltd. |
04/21/2025 | HGX |
| K243383 | CHIKAI Nexus 014 | ASAHI INTECC CO., LTD. | 04/21/2025 | MOF |
| K242254 | D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter |
DK Medical Technology Co., Ltd. |
04/21/2025 | PNO |
| K250842 | PADLOCK CLIP EFTR Kit (00713229) |
STERIS Corporation | 04/18/2025 | PKL |
| K250834 | Zimmer Biomet Ceramic Heads (22.2mm Diameter) |
Zimmer Biomet | 04/18/2025 | LZO |
| K250481 | Extension Feeding Set With ENFit™ Connectors |
Sky Medical, a.s. | 04/18/2025 | PIF |
| K250459 | DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution |
Technoflex SAS. | 04/18/2025 | KPE |
| K250224 | Handlite (TN19S) | iSMART Developments LTD | 04/18/2025 | ONE |
| K250146 | SofWave System | Sofwave Medical Ltd. | 04/18/2025 | NGX |
| K243734 | Wireless/ Wired X-Ray Flat Panel Detectors |
Allengers Medical Systems Limited |
04/18/2025 | MQB |
| K243013 | LIAISON PLEX Gram-Negative Blood Culture Assay |
Luminex Corporation | 04/18/2025 | PEN |
| K242170 | K-ASSAY CRP (Ver.2) | Kamiya Biomedical Company, LLC |
04/18/2025 | DCK |
| K241996 | ULTRA 1040 | ECORAY Co., Ltd. | 04/18/2025 | IZL |
| K241188 | Acucy® Influenza A&B Test With The Acucy® 2 System |
Sekisui Diagnostics, LLC | 04/18/2025 | PSZ |
| K240775 | PeriBeam® Pericardial Membrane |
TamaBio | 04/18/2025 | DXZ |
| K240355 | FROG (Filter Removal Of Glass) | CarrTech Corp | 04/18/2025 | FMI |
| K250889 | EXULT Knee Replacement System | Corentec Co., Ltd. | 04/17/2025 | JWH |
| K250829 | Lacevo Wearable Breast Pump (Model S70) |
Shenzhen TPH Technology Co., Ltd. |
04/17/2025 | HGX |
| K250499 | RELiZORB (100300/100301) | Alcresta Therapeutics, Inc |
04/17/2025 | PLQ |
| K250455 | FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM) |
FLUOPTICS SAS (a Getinge Group Company} |
04/17/2025 | QDG |
| K250270 | Luja Set | Coloplast Corp | 04/17/2025 | EZD |
| K243878 | CLARUS (700) | Carl Zeiss Meditec, Inc. | 04/17/2025 | QER |
| K243750 | SimpleStitch Suturing System | Envision Endoscopy | 04/17/2025 | OCW |
| K243460 | Ultimate Rtms | Brain Ultimate, Inc. | 04/17/2025 | OBP |
| K243459 | Ultimate Rtms For OCD (M-series) |
Brain Ultimate, Inc. | 04/17/2025 | QCI |
| K243337 | Dental Cone Beam Computed Tomography System |
Yofo Medical Technology Co., Ltd. |
04/17/2025 | OAS |
| K242992 | RayCare (2024A SP1) | RaySearch Laboratories AB (publ) |
04/17/2025 | MUJ |
| K242337 | FlowGuide (FG60F); GuidionShort (GS60F) |
IMDS Operations B.V. | 04/17/2025 | DQY |
| K242129 | VitalRhythm | VitalConnect, Inc. | 04/17/2025 | DQK |
| K242056 | Miacare (DELiGHT Daily Wear/ DELiGHT 1-day/ CONFiDENCE Color Daily Wear/confidence Color 1-day) Contact Lens With EautraSil Plus |
BenQ Materials Corporation |
04/17/2025 | LPL |
| K250850 | Nanox.ARC X | Nano-x Imaging Ltd. | 04/16/2025 | IZF |
| K250809 | Stellar M22 | Lumenis Be Ltd. | 04/16/2025 | GEX |
| K243853 | Clarius Prostate AI | Clarius Mobile Health Corp. |
04/16/2025 | QIH |
| K243513 | DCM (PW-DCM) | PneumoWave, Ltd | 04/16/2025 | LEL |
| K242806 | Medyssey Navigation System | Medyssey Co, Ltd. | 04/16/2025 | OLO |
| K242647 | MySegmenter (v2.0.0) | MySegmenter Technologies Inc. |
04/16/2025 | LLZ |
| K242500 | LARALAB | LARALAB GmbH | 04/16/2025 | QIH |
| K241733 | HEBE (NP0000763); HERA (NP0000706) |
Novasonix Technology S.L | 04/16/2025 | PBX |
| K250833 | SwissMembrane X; SwissMembrane X Socket |
Geistlich Pharma AG | 04/15/2025 | NPL |
| K250824 | Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent Set |
Boston Scientific Corporation |
04/15/2025 | FAD |
| K250803 | Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup |
ANHUI Deepblue Medical Technological Co., Ltd. |
04/15/2025 | NGL |
| K250650 | SpotLight / SpotLight Duo With Low Dose Lung Cancer Screening Option |
Arineta Ltd. | 04/15/2025 | JAK |
| K250327 | OptaBlate Radiofrequency (RF) Generator System |
Stryker Instruments | 04/15/2025 | GEI |
| K250212 | LapBox Power Tissue Containment System |
ARK Surgical | 04/15/2025 | PMU |
| K243055 | Préime DermaFacial Collagen+ | EMA Aesthetics, LTD | 04/15/2025 | PBX |
| K242932 | Skin Clinic Nitro Clear Wart Remover |
CryoConcepts LP | 04/15/2025 | GEH |
| K242786 | TearCare MGX System | Sight Sciences, Inc. | 04/15/2025 | ORZ |
| K242773 | Electro Lube NXT | Steris | 04/15/2025 | GEI |
| K242658 | The Sensititre 18-24 Hour MIC Or Breakpoint Susceptibility System With Moxifloxacin In The Dilution Range Of 0.008-16 Ug/ml |
Thermofisher Scientific | 04/15/2025 | JWY |
| K250823 | Any-Com Flow | Mediclus Co., Ltd. | 04/14/2025 | EBF |
| K250802 | STERRAD® 100NX Sterilizer With ALLClear™ Technology (10104) |
Advanced Sterilization Products Inc. |
04/14/2025 | MLR |
| K250402 | AVAVA™ Skin Treatment System | Avava Inc | 04/14/2025 | ONG |
| K250301 | Merge Universal Viewer (MUV) | Merge Healthcare Incorporated |
04/14/2025 | LLZ |
| K250094 | Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014) |
Neuralynx, Inc. | 04/14/2025 | GYC |
| K243852 | Elfor-L | Elfi-Tech Ltd. | 04/14/2025 | DPW |
| K250811 | Dental Zirconia Ceramic | Aidite (Qinhuangdao) Technology Co., Ltd. |
04/11/2025 | EIH |
| K250748 | KLAXON (TWIST); KLAXON (TWIST R) |
KLAXON-MOBILITY GmbH | 04/11/2025 | ITI |
| K250438 | CooperSurgical Milex® Pessaries |
CooperSurgical, Inc | 04/11/2025 | HHW |
| K250416 | GBrain MRI | Galileo CDS, Inc | 04/11/2025 | QIH |
| K250081 | Atlantis® Abutments In Titanium |
Dentsply Sirona | 04/11/2025 | NHA |
| K243921 | LED Curing Lights (DB686 HALO) | Foshan COXO Medical Instrument Co., Ltd. |
04/11/2025 | EBZ |
| K243898 | Chlorine Sentinel II | Nelson Environmental Technologies, Inc. |
04/11/2025 | MSY |
| K243888 | Medline UNITE® REFLEX® Hybrid Nitinol Implant System |
Medline Industries, LP | 04/11/2025 | JDR |
| K243857 | Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US) |
Shanghai AnQing Medical Instrument Co., Ltd. |
04/11/2025 | FGB |
| K243710 | Disposable Ureteral Access Sheath |
Shenzhen Trious Medical Technology Co., Ltd |
04/11/2025 | FED |
| K243558 | Canvas Dx | Cognoa, Inc. | 04/11/2025 | QPF |
| K243537 | XeliteMed VertehighFix High Viscosity Spinal Bone Cement System |
XELITE BIOMED LTD. | 04/11/2025 | NDN |
| K243356 | Asiga DentaBASE | Asiga Pty Ltd | 04/11/2025 | EBI |
| K243346 | Cobas Liat SARS-CoV-2 V2 Nucleic Acid Test |
Roche Molecular Systems, Inc. |
04/11/2025 | QWR |
| K243260 | FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R |
Fujifilm Corporation | 04/11/2025 | FET |
| K243044 | Alma Harmony | Alma Lasers, Inc. | 04/11/2025 | GEX |
| K242772 | AirSurgN Insufflator (10030/AirSurgN) |
SmartSurgN Inc | 04/11/2025 | HIF |
| K242748 | Oncospace | Oncospace, Inc. | 04/11/2025 | MUJ |
| K242646 | Dental Implant Unit | Guilin AestheDent Medical Instruments Co., Ltd |
04/11/2025 | EBW |
| K242600 | Second Opinion Periapical Radiolucency Contours |
Pearl Inc. | 04/11/2025 | MYN |
| K242120 | OTOPLAN | Cascination AG | 04/11/2025 | QQE |
| K242098 | Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2) |
Shenzhen Vivolight Medical Device & Technology Co., Ltd. |
04/11/2025 | NQQ |
| K250754 | Cmangio® (V1.6) | CureMetrix, Inc. | 04/10/2025 | QIH |
| K250486 | Skyway Anterior Cervical Plate System |
Kyocera Medical Technologies, Inc. (KMTI) |
04/10/2025 | KWQ |
| K250389 | XNY Disposable Gastric Calibration Tube |
Changzhou Xin Neng Yuan Medical Stapler Co., Ltd. |
04/10/2025 | KNT |
| K250371 | Cryoice Cryoxt Cryoablation Probe (cryoXT) |
AtriCure, Inc. | 04/10/2025 | GXH |
| K250177 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System |
Philips Ultrasound LLC | 04/10/2025 | IYN |
| K250112 | FitboneTM Trochanteric | Orthofix srl | 04/10/2025 | HSB |
| K250058 | NEAT 001 | Brain Electrophysiology Laboratory Company, LLC |
04/10/2025 | OLZ |
| K250009 | LED Curing Light (C01-X, C02-X) |
Premium Plus (Dongguan) Limited |
04/10/2025 | EBZ |
| K243953 | Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color) |
VizionFocus Inc. | 04/10/2025 | LPL |
| K243943 | TriMed® Compression Screws | TriMed, Inc. | 04/10/2025 | HWC |
| K243240 | Vitrea CT VScore | Canon Medical Informatics, Inc. |
04/10/2025 | JAK |
| K243145 | Syngo.ct LVO Detection | Siemens Medical Solutions USA, Inc. |
04/10/2025 | QAS |
| K242928 | Tesera-k SC System | Kyocera Medical Technologies, Inc. |
04/10/2025 | OVE |
| K242561 | Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit) |
DonneVie Medical Technology (Shanghai) Co. Ltd. |
04/10/2025 | MQL |
| K242089 | Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202) |
Jiangsu Ruifuda Medical Device Co., Ltd |
04/10/2025 | MQL |
| K242045 | Initia T3 Acetabular Hemispherical Shell System |
Kyocera Medical Technologies, Inc. |
04/10/2025 | LPH |
| K250752 | AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) |
Integra LifeSciences Corporation |
04/09/2025 | GWG |
| K250373 | ProLift Expandable Spacer System |
Life Spine, Inc. | 04/09/2025 | MAX |
| K250098 | Bard Soft Mesh; Bard Soft Mesh Pre-Shaped |
Davol Inc. | 04/09/2025 | FTL |
| K243966 | FaceHeart Vitals Software Development Kit (FH Vitals SDK-RR) |
FaceHeart Corp. | 04/09/2025 | BZQ |
| K243819 | Luminopia | Luminopia, Inc. | 04/09/2025 | QQU |
| K243743 | Autoscore (V 2.0.0) | Holberg EEG AS | 04/09/2025 | OMB |
| K243613 | Patch-TEA (Model TRI-21) | Transtimulation Research, Inc |
04/09/2025 | NUH |
| K243214 | Dexcom G7 15 Day Continuous Glucose Monitoring System |
Dexcom, Inc. | 04/09/2025 | QBJ |
| K242429 | CentroVena Central Venous Catheter (CVC) With The CentroVena One Insertion System |
Becton Dickinson Inc. (BD) |
04/09/2025 | SEF |
| K241589 | Ceribell Seizure Detection Software |
Ceribell, Inc. | 04/09/2025 | OMB |
| K250948 | TriMed Fusion Cup System | TriMed, Inc. | 04/08/2025 | HRS |
| K250708 | NPseal | Guard Medical, Inc. | 04/08/2025 | OKO |
| K250366 | Electric Wheelchair (LW01301A07) |
Anhui Longway Medical Technology Co., LTD |
04/08/2025 | ITI |
| K250343 | LuxCreo Clear Aligner System | LuxCreo Inc. | 04/08/2025 | NXC |
| K250136 | Globalcare Blood Pressure Monitor (GUS610) |
Globalcare Medical Technology Co., Ltd |
04/08/2025 | DXN |
| K243967 | ONE Nitrile Condom | Global Protection Corp. | 04/08/2025 | MOL |
| K243749 | Jmoon Conductive Gel | Shenzhen Ulike Smart Electronics Co., Ltd. |
04/08/2025 | GYB |
| K243722 | Pre-B Seal Lung Biopsy Plug System - 15cm Model (FG0001); Pre-B Seal Lung Biopsy Plug System - 16cm Model (FG0002); Pre-B Seal Lung Biopsy Plug System - 20cm Model (FG0003) |
Selio Medical Limited | 04/08/2025 | OMT |
| K243027 | Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27) |
Hangzhou Sightnovo Medical Technology Co., Ltd. |
04/08/2025 | QLY |
| K242552 | Horos Mobile | iCat Solutions Ltd | 04/08/2025 | LLZ |
| K242295 | BunkerHill BMD | BunkerHill Health | 04/08/2025 | KGI |
| K242151 | Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B) |
Shenzhen Nuon Medical Equipment Co., Ltd |
04/08/2025 | OHS |
| K250521 | NanoBone® SBX Putty ; NanoBone® QD |
Biocomposites Ltd | 04/07/2025 | MQV |
| K250425 | Ultraviolet Phototherapy Device |
APK Technology Co., Ltd. | 04/07/2025 | FTC |
| K250395 | BioBrace ® RC Delivery System | CONMED Corporation | 04/07/2025 | ORQ |
| K250033 | Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E) |
Guangzhou Pinzhi Medical Technology Co., LTD |
04/07/2025 | NUH |
| K243567 | Tyto Insights For Rhonchi Detection |
Tyto Care Ltd. | 04/07/2025 | PHZ |
| K243143 | E-PEN (E-PEN) | BOMTECH ELECTRONICS CO., LTD. |
04/07/2025 | QAI |
| K242385 | LED Therapy Mask (MN1, M226) | Shenzhen Borria Technology Co., Ltd |
04/07/2025 | OHS |
| K250727 | AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup |
Hangzhou Alltest Biotech Co.,Ltd |
04/04/2025 | NFT |
| K250706 | Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter |
BIOTRONIK, Inc. | 04/04/2025 | LIT |
| K250667 | DeGen Medical Patient Specific Implant (PSI) System |
DeGen Medical | 04/04/2025 | MAX |
| K250656 | Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75) |
Wuhan Pioon Technology Co.,Ltd. |
04/04/2025 | GEX |
| K250332 | Virage® OCT Spinal Fixation System |
Highridge Medical, LLC | 04/04/2025 | NKG |
| K250011 | Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000) |
Turbett Surgical | 04/04/2025 | FRG |
| K243786 | Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G) |
Fresenius Medical Care Renal Therapies Group, LLC |
04/04/2025 | KPO |
| K243769 | QFR (3.0) | QFR Solutions bv | 04/04/2025 | QHA |
| K243691 | LiquID .051 LP Guide Catheter Extension |
Seigla Medical, Inc. | 04/04/2025 | DQY |
| K243581 | K-Pack Enhance Needle (KH-2713RBBTC And KH-2913RBBTC) |
Terumo Europe N.V. | 04/04/2025 | FMI |
| K243549 | JETi Hydrodynamic Thrombectomy System |
Abbott Medical | 04/04/2025 | QEZ |
| K243236 | WHOOP ECG (electrocardiogram) Feature (1.0) |
Whoop, Inc. | 04/04/2025 | QDA |
| K243074 | Spectrum Spine Lumbar Cage System |
Spectrum Spine, Inc. | 04/04/2025 | MAX |
| K242807 | HeartFocus (V.1.1.1) | Deski | 04/04/2025 | QJU |
| K242769 | VentStar Resus Heated (N) (MP17030); VentStar Autobreath Heated (N) (MP17031) |
Draegerwerk AG & Co. KGaA |
04/04/2025 | |
| K242576 | AllTest Viral Transport Medium | Hangzhou Alltest Biotech Co.,Ltd |
04/04/2025 | JSM |
| K242209 | UASure II Blood Uric Acid Monitoring System |
Apex Biotechnology Corp | 04/04/2025 | PTC |
| K242116 | EyeBOX EBX-4.1 | Oculogica, Inc. | 04/04/2025 | QEA |
| K242103 | TRIOS Ready Tip | 3Shape TRIOS A/S | 04/04/2025 | NBL |
| K242068 | LED Light Therapy Mask (RT01) | Ningbo Dechang Electrical Machinery Made Co.,Ltd |
04/04/2025 | OLP |
| K242001 | Philips VSC-MEDlib | Philips Medical Systems Nederland B.V. |
04/04/2025 | BZQ |
| K241982 | DeepFoqus (DeepFoqus-Accelerate) |
Foqus Technologies Inc. | 04/04/2025 | QIH |
| K240398 | RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3 |
RaySearch Laboratories AB (publ) |
04/04/2025 | MUJ |
| K250658 | SureFine Pen Needle | SHINA MED CORPORATION | 04/03/2025 | FMI |
| K250404 | Stay•safe® Catheter Extension Set With Safe- Lock, 12 Inch; Stay•safe® Catheter Extension Set With Luer-Lock, 6 Inch; Stay•safe® Catheter Extension Set With Luer-Lock, 12 Inch; Stay•safe® Catheter Extension Set With Luer-Lock, 18 Inch; Stay•safe® To Luer-Lock Adapter, 4 Inch |
Fresenius Medical Care Renal Therapies Group, LLC |
04/03/2025 | KDJ |
| K243936 | StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) |
StaClear, INC. | 04/03/2025 | QLY |
| K243760 | OSSIOfiber® Suture Anchor 2.5-3.5 Mm |
Ossio Ltd. | 04/03/2025 | MAI |
| K243514 | Salvo® Robotic Navigation Instruments |
Spine Wave, Inc. | 04/03/2025 | OLO |
| K243305 | Masimo W1 | Masimo Corporation | 04/03/2025 | DPS |
| K243298 | Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System |
Carbon (Shenzhen) Medical Device Co., Ltd. |
04/03/2025 | IYN |
| K242551 | Syngo Dynamics (Version VA41D) | Siemens Healthcare GmbH | 04/03/2025 | QIH |
| K242358 | Powered Wheelchair (mobility Robot) (M4, M4U) |
XSTO CO., LTD. | 04/03/2025 | ITI |
| K240615 | Leos Laser And Endoscopy System |
Beaver-Visitec International, Inc. |
04/03/2025 | HQF |
| K250930 | Twiist System | DEKA Research & Development Corp. |
04/02/2025 | QFG |
| K250760 | SPECTRUM GV Bone Cement | OsteoRemedies, LLC | 04/02/2025 | LOD |
| K250705 | Sonata Transcervical Fibroid Ablation System 2.2 |
Gynesonics, Inc. | 04/02/2025 | KNF |
| K250677 | LEGION Total Knee System | Smith & Nephew, Inc. | 04/02/2025 | JWH |
| K250613 | SnapHammer Hammertoe Correction System |
Nvision Biomedical Technologies Inc |
04/02/2025 | HWC |
| K250152 | Eufy Wearable Breast Pump S1 (T8D02) Model T8D02; Eufy Wearable Breast Pump E10 (T8D03) Model T8D03; Eufy Wearable Breast Pump S1 Pro (T8D04) Model T8D04; Eufy Wearable Breast Pump E20 (T6060) Model T6060; |
Shenzhen TPH Technology Co., Ltd. |
04/02/2025 | HGX |
| K250138 | Small Volume 0.2mL Syringe | Prosum Medical Limited | 04/02/2025 | QNQ |
| K243889 | Remplir (ON-152, 15 X 20 Mm); Remplir (ON-203, 20 X 30 Mm); Remplir (ON-304, 30 X 40 Mm); Remplir (ON-405, 40 X 50 Mm) |
Orthocell Ltd. | 04/02/2025 | JXI |
| K243733 | SION Blue PLUS | ASAHI INTECC CO., LTD. | 04/02/2025 | DQX |
| K243659 | FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments |
SeaSpine Orthopedics Corporation |
04/02/2025 | OLO |
| K242460 | Progenix Select Stim | Progenix LLC | 04/02/2025 | NUH |
| K242117 | LifeShield Infusion Safety Software Suite |
ICU Medical, Inc. | 04/02/2025 | PHC |
| K242115 | Plum Duo™ Precision IV Pump | ICU Medical Inc. | 04/02/2025 | FRN |
| K242114 | Plum Solo™ Precision IV Pump | ICU Medical Inc | 04/02/2025 | FRN |
| K242113 | Nerve Wrap (07-DW-001-TAB) | BioCircuit Technologies, Inc. |
04/02/2025 | JXI |
| K242067 | VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA |
Olympus Corporations of the Americas |
04/02/2025 | FET |
| K242031 | Béa Applicator (BAP-GB-01) | StepOne Fertility Ltd (t/a Béa Fertility) |
04/02/2025 | HDR |
| K241984 | Hi-D Imaging 4TAVR | Hi-D Imaging AG | 04/02/2025 | QIH |
| K250623 | Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur |
OrthoPediatrics Corp. | 04/01/2025 | HSB |
| K250578 | Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black) |
Careglove Global Sdn. Bhd. |
04/01/2025 | LZA |
| K250189 | AdvaTx | AdvaLight APS | 04/01/2025 | GEX |
| K250018 | Medical Diode Laser Systems (THEIA808) |
Gigaalaser Company Ltd. | 04/01/2025 | GEX |
| K243938 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire |
Scientia Vascular Inc | 04/01/2025 | MOF |
| K243072 | Préime DermaFacial (MicroT) | EMA Aesthetics, LTD | 04/01/2025 | NFO |
| K242925 | MR Contour DL | GE HealthCare | 04/01/2025 | QKB |
| K242427 | Da Vinci Xi Surgical System (IS4000); Da Vinci X Surgical System (IS4200) |
Intuitive Surgical, Inc. | 04/01/2025 | NAY |
| K242105 | SABA Tampons | Essity Higiene Y Salud Mexico. S.A. DE C.V. |
04/01/2025 | HEB |
| K242041 | STOPWET Iontophoresis Apparatus (SW01) |
Taiwan Medical Electronics Co., Ltd. |
04/01/2025 | EGJ |
| K250946 | Denture Base Resin DT20 | Hangzhou SHINING3D Dental Technology Co., Ltd. |
03/31/2025 | EBI |
| K250663 | Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent |
Taewoong Medical Co., Ltd. |
03/31/2025 | MUM |
| K250263 | Disposable Grasping Forceps FG-52D/FG-54D |
Olympus Medical Systems Corp. |
03/31/2025 | KTI |
| K243384 | Belzer UW® Cold Storage Solution (BTLBUW-001) |
Bridge to Life | 03/31/2025 | KDN |
| K243178 | Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler Ultrasound Imaging System (Apogee C2); Digital Color Doppler Ultrasound Imaging System (Apogee C3); Digital Color Doppler Ultrasound Imaging System (Apogee C5); Digital Color Doppler Ultrasound Imaging System (Apogee K1); Digital Color Doppler Ultrasound Imaging System (Apogee K2); Digital Color Doppler Ultrasound Imaging System (Apogee K3); Digital Color Doppler Ultrasound Imaging System (Apogee K5); Di |
Shantou Institute of Ultrasonic Instruments Co., Ltd. |
03/31/2025 | |
| K242166 | TribusConnect | TribusMed Beheer BV | 03/31/2025 | QIH |
| K250601 | Neuro Omega System; NeuroSmart System |
Alpha Omega Engineering Ltd. |
03/30/2025 | GZL |
| K242618 | Layer 7-T | Precision Neuroscience, Corp. |
03/30/2025 | GYC |
| K250596 | Arthrex FiberTak Suture Anchor | Arthrex Inc. | 03/28/2025 | MBI |
| K250571 | CATALYSTEM Femoral Stems | Smith & Nephew Inc. | 03/28/2025 | LZO |
| K244044 | PBC Separator With Selux AST System |
Selux Diagnostics, Inc. | 03/28/2025 | QZX |
| K244030 | Needle Stimulator (CMNS6-1 PLUS, CMNS6-3) |
Wuxi Jiajian Medical Instrument Co., Ltd. |
03/28/2025 | BWK |
| K243520 | Bullsai Confirm | Turing Medical Technologies, Inc. |
03/28/2025 | QQC |
| K243228 | Flexi-Seal AIR (with ENFit Connector) |
Convatec | 03/28/2025 | KNT |
| K242952 | INNOVANCE Antithrombin | Siemens Healthcare Diagnostic Products GmbH |
03/28/2025 | JBQ |
| K242022 | Access Toxo IgG | Beckman Coulter Inc. | 03/28/2025 | LGD |
| K241927 | Synthes Graphic Case & Tray System |
Synthes GmbH | 03/28/2025 | KCT |
| K234067 | ImagingRing M (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0) |
medPhoton GmbH | 03/28/2025 | OWB |
| K233953 | Makani Science™ Respiration Monitoring System |
Makani Science, Inc. | 03/28/2025 | BZQ |
| K250558 | SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315) |
Medtronic, Inc. | 03/27/2025 | DQY |
| K250555 | MallyaD Injection Pen Adapter (MallyaD) |
BioCorp Production | 03/27/2025 | QOG |
| K250092 | HC Biologics Osteopoint Spinal Fixation System |
HC Biologics LLC | 03/27/2025 | NKB |
| K244059 | HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104) |
Access Vascular, Inc. | 03/27/2025 | FOZ |
| K244046 | Edwards Esheath Optima Introducer Set |
Edwards Lifesciences | 03/27/2025 | DYB |
| K243768 | Itotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System |
restor3d, inc. | 03/27/2025 | MBH |
| K243708 | Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.) |
Scivita Medical Technology Co., Ltd. |
03/27/2025 | FGB |
| K243426 | Nurochek-Pro System | Headsafe MFG Pty Ltd | 03/27/2025 | PIW |
| K243038 | Salix Central | Artrya Limited | 03/27/2025 | QIH |
| K242919 | V5med Lung AI | V5med Inc. | 03/27/2025 | OEB |
| K242745 | AI-Rad Companion Organs RT | Siemens Healthcare GmbH | 03/27/2025 | QKB |
| K242201 | HyperSuture White/Green Extension Line |
Threadstone LLC | 03/27/2025 | GAT |
| K241962 | Crossloop | Asahi Intecc Co., Ltd. | 03/27/2025 | DQX |
| K241862 | Levina Pelvic Floor Muscle Stimulator (RS-48) |
ZMI Electronics Ltd. | 03/27/2025 | KPI |
| K241785 | StarFormer (M008-3T) | Fotona d.o.o. | 03/27/2025 | QPL |
| K250542 | AC3™ Range™ Intra-Aortic Balloon Pump |
Arrow International LLC | 03/26/2025 | DSP |
| K250194 | Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH) |
Shenzhen Ulike Smart Electronics Co.,Ltd. |
03/26/2025 | OHT |
| K250134 | Power Wheelchair (YH-E6011,YH-E6013A) |
Ningbo Youhuan Automation Technology Co., Ltd. |
03/26/2025 | ITI |
| K244003 | Electrically Powered Wheelchair |
Kunshan Hi-Fortune Health Products Co., Ltd |
03/26/2025 | ITI |
| K243995 | Arthrex Humeral Plating System And Cerclage Button |
Arthrex Inc. | 03/26/2025 | HRS |
| K243891 | EarliPoint System | EarliTec Diagnostics | 03/26/2025 | QPF |
| K243840 | Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) |
Bridge to Life | 03/26/2025 | KDN |
| K243831 | Rayvolve LN | AZmed | 03/26/2025 | MYN |
| K242669 | SnapshotGLO (KB100) | Kent Imaging Inc. | 03/26/2025 | QJF |
| K241855 | SB Knife Jr2 (MD-47702 And MD-47702L) |
SB-KAWASUMI LABORATORIES, INC. |
03/26/2025 | KNS |
| K240189 | NM-01/CPT Neurometer (NM-01/CPT) |
MDE Orvosbiológiai Kutató, Fejleszto, |
03/26/2025 | JXE |
| K250668 | Aventus Thrombectomy System (IM-2100) |
Inquis Medical | 03/25/2025 | QEW |
| K250225 | Bolt Intravascular Lithotripsy (IVL) System |
Bolt Medical, Inc. | 03/25/2025 | PPN |
| K250603 | AxTiHA® Stand-Alone ALIF System |
Innovasis | 03/24/2025 | OVD |
| K250182 | Innovasis Navigation Instruments |
Innovasis, Inc. | 03/24/2025 | OLO |
| K250125 | LMNT O2 | XPLR Ltd. | 03/24/2025 | OHS |
| K250013 | VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S, VS8-MP90S, VS8-MP100B, VS10-MP100B, VS11-MP60S, VS11-MP90S, VS12-MP100B, 7F-MP60S, 7F-MP90S, 8F-MP60S, 8F-MP100B, 10F-MP100B, 11F-MP60S, 11F-MP90S, 11P-MP60S, 11P-MP90S, 12F-MP100B, V30-ASP) |
Control Medical Technology, Inc. / dba VentiV Scientific |
03/24/2025 | QEZ |
| K243991 | Klassic Knee System - Revision Tibial Baseplate |
Total Joint Othopedics, Inc. |
03/24/2025 | JWH |
| K243930 | Sonopet Iq Ultrasonic Aspirator System (5500-050-000) |
Stryker Instruments | 03/24/2025 | LFL |
| K243865 | AERO MIS Facet Fusion System | Aurora Spine | 03/24/2025 | MRW |
| K243642 | UltraCor™ Twirl™ Breast Tissue Marker |
Bard Peripheral Vascular, Inc. |
03/24/2025 | NEU |
| K243525 | SonoTAP And SonoTAP II | PAJUNK GmbH Medizintechnologie |
03/24/2025 | BSP |
| K243052 | Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter)) |
Bright Uro, Inc. | 03/24/2025 | EXQ |
| K242893 | VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System |
Luma Vision Limited | 03/24/2025 | OBJ |
| K242356 | TIDAL Fusion Cage System | restor3d, Inc. | 03/24/2025 | SAI |
| K241921 | Alinity M BKV | Abbott Molecular Inc. | 03/24/2025 | QMI |
| K250561 | Natural Cycles | NaturalCycles Nordic AB | 03/21/2025 | PYT |
| K250556 | Porous Biologic Scaffold | Ventris Medical | 03/21/2025 | MQV |
| K250517 | Navigator™ HD Ureteral Access Sheath Set 11/13 F X 28cm (M0062502210); Navigator™ HD Ureteral Access Sheath Set 11/13 F X 36cm (M0062502220); Navigator™ HD Ureteral Access Sheath Set 11/13 F X 46cm (M0062502230); Navigator™ HD Ureteral Access Sheath Set 12/14 F X 28cm (M0062502240); Navigator™ HD Ureteral Access Sheath Set 12/14 F X 36cm (M0062502250); Navigator™ HD Ureteral Access Sheath Set 12/14 F X 46cm (M0062502260); Navigator™ HD Ureteral Access Sheath Set 13/15 F X 28cm (M006 |
Boston Scientific Corporation |
03/21/2025 | FED |
| K250513 | IntelliSep Test (CV-ICG-048) | Cytovale, Inc. | 03/21/2025 | QUT |
| K250403 | Catamaran SI Joint Fusion System |
Tenon Medical | 03/21/2025 | OUR |
| K250186 | GoLIF! Lumbar Interbody Fusion System |
GetSet Surgical, SA | 03/21/2025 | MAX |
| K250106 | Signos Glucose Monitoring System |
Signos, Inc. | 03/21/2025 | SAF |
| K243980 | ARVIS Surgical Navigation System |
Kico Knee Innovation Company Pty Limited |
03/21/2025 | SBF |
| K243958 | Consolidated Operating Room Equipment (CORE) 2 Console |
Stryker Instruments | 03/21/2025 | OLO |
| K243808 | Rayvolve PTX-PE | AZmed | 03/21/2025 | QFM |
| K243649 | BD Vacutainer® Multiple Sample Luer Adapter |
Becton Dickinson and Company |
03/21/2025 | JKA |
| K243630 | Medical Laser System Incanto / Evoline Platinum /Evoline |
SOLAR LS CJSC | 03/21/2025 | GEX |
| K243451 | FiAPC Plus Probes | Erbe Elektromedizin GmbH | 03/21/2025 | GEI |
| K243185 | REMI Remote EEG Monitoring System |
Epitel | 03/21/2025 | OMC |
| K243032 | EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) |
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. |
03/21/2025 | FFK |
| K242909 | FloTrac Sensors; FloTrac Jr Sensors; Acumen IQ Sensors; VolumeView Sensors |
Edwards Lifesciences, LLC |
03/21/2025 | DRS |
| K242888 | Electrohydraulic Lithotriptor (TCS-B3-II) |
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. |
03/21/2025 | FFK |
| K242564 | Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit) |
Prismatik Dentalcraft, Inc. |
03/21/2025 | KCT |
| K242289 | Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter |
Stryker Neurovascular | 03/21/2025 | QJP |
| K242107 | CaseMONO™ Culture (CMON); CaseMONO™ W/hepes (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF W/hepes (HHTF) |
CaseBioscience, Inc. | 03/21/2025 | MQL |
| K242053 | FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) |
Fresenius Medical Care Renal Therapies Group, LLC |
03/21/2025 | KDI |
| K241890 | Philips Holter Analysis System | Philips Medizin Systeme Böblingen GmbH |
03/21/2025 | MLO |
| K241833 | V-GRAD | VITROMED GmbH | 03/21/2025 | MQL |
| K241065 | ChecQ (AC100) | DENTIS Co., Ltd. | 03/21/2025 | EKX |
| K240761 | Arisure® Closed Male Luer With Spike Adapter (YM060) |
Yukon Medical, LLC | 03/21/2025 | LHI |
| K250468 | Isleeve Introducer Set | Boston Scientific | 03/20/2025 | DYB |
| K250463 | Ameda GLO Wearable Breast Pump (Model W8S) |
Shenzhen TPH Technology Co., Ltd. |
03/20/2025 | HGX |
| K243988 | RootMend MRR | Riverpoint Medical LLC | 03/20/2025 | MBI |
| K243975 | Knee+ | Pixee Medical | 03/20/2025 | SBF |
| K243928 | ViaOne Epicardial Access System |
CardioVia Ltd. | 03/20/2025 | DYB |
| K243922 | Revogene | Meridian Bioscience, Inc. |
03/20/2025 | OOI |
| K243292 | Brain™ Shoulder Positioning | Avatar Medical | 03/20/2025 | LLZ |
| K243016 | Starlight Imaging Catheter | SpectraWAVE, Inc. | 03/20/2025 | NQQ |
| K242958 | Joylux Intimacy Gel (PG3100) | Joylux, Inc | 03/20/2025 | NUC |
| K242771 | Tesera-k PL System And Tesera-k XL System |
Kyocera Medical Technologies, Inc. |
03/20/2025 | MAX |
| K242770 | EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG |
DRTECH Corporation | 03/20/2025 | MQB |
| K241961 | Vent Creativity Knee V1.0 (Hermes) |
Vent Creativity | 03/20/2025 | QIH |
| K241884 | HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38) |
Hunan Haipuming Technology Co., Ltd. |
03/20/2025 | LPL |
| K241704 | Endoscopic Water Pump | Hangzhou AGS MedTech Co., Ltd. |
03/20/2025 | OCX |
| K250502 | SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000) |
SafeSource Direct LLC | 03/19/2025 | LZA |
| K250429 | DSPS-Prominent® Baseplate, MR (113820); DSPS-Prominent® Baseplate (113120); DSPS-Prominent® Cradle-I (113140); DSPS-Prominent® Cradle-II (113150); DSPS-Prominent® Cradle-III (113160); DSPS-Prominent® Cradle-IV (113170); DSPS-Prominent® Cradle-VI (113180); DSPS-Prominent® Cradle-VII (113260); Mask DSPS®-PROSCVRL Set/5 (113760); Mask DSPS®-PROSC Set/5 (113770); Mask DSPS®-PROSCVR Set/5 (113780); Mask DSPS®-PROSCL Set/5 (113790); Mask DSPS®-PROSHVRL Set/5 (113890); Mask DSPS®-PROSH Set |
MacroMedics BV | 03/19/2025 | IYE |
| K250210 | Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D)) |
Scivita Medical Technology Co.,Ltd. |
03/19/2025 | EOQ |
| K250171 | IPL Hair Removal Device (BE965A, BE965B, BE965C) |
Shenzhen Yang Wo Electronic Co., Ltd. |
03/19/2025 | OHT |
| K250131 | IPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011, M7012, M7021, M7023) |
Mustech Electronics Co., Limited |
03/19/2025 | OHT |
| K250042 | PeekMed Web | Peek Health, S.A. | 03/19/2025 | QIH |
| K243999 | TriMed Ankle Fixation System | TriMed, Inc. | 03/19/2025 | HRS |
| K243987 | TriMed Elbow And Forearm System |
TriMed, Inc. | 03/19/2025 | HRS |
| K243689 | AVIEW | Coreline Soft Co., Ltd. | 03/19/2025 | QIH |
| K243472 | 1NEED Pro | Campomats S.r.l. | 03/19/2025 | QAI |
| K243443 | EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP |
DRTECH Corporation | 03/19/2025 | MQB |
| K243092 | AcuPebble Ox (200) | Acurable Limited | 03/19/2025 | MNR |
| K242486 | Tyber Medical Anatomical Plating System |
Tyber Medical, LLC | 03/19/2025 | HRS |
| K242241 | Sunny | ShenB Co., Ltd | 03/19/2025 | GEI |
| K241842 | Luer-Split MAJ-2092 | Olympus Medical Systems Corporation |
03/19/2025 | ODC |
| K241791 | Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D) |
Gigaalaser Company Ltd. | 03/19/2025 | GEX |
| K250494 | The OsteoCentric Bone Plate And Screw System |
OsteoCentric Technologies |
03/18/2025 | HRS |
| K250413 | Aglaia LED Beauty Device (BP-D2309) |
Shenzhen Perfect Idea Technology Limited |
03/18/2025 | OHS |
| K243807 | Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P |
Olympus Medical Systems Corp. |
03/18/2025 | LQR |
| K243556 | Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) |
iRay Imaging Technology (Haining) Limited |
03/18/2025 | MQB |
| K243553 | QuikClot Control+ Hemostatic Device |
Teleflex Medical | 03/18/2025 | POD |
| K242683 | QP-Prostate® CAD | Quibim S.L. | 03/18/2025 | QDQ |
| K242533 | Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested For Use With Chemotherapy Drugs And Fentanyl Citrate |
Better Care Plastic Technology Co., Ltd. |
03/18/2025 | LZA |
| K242161 | Radlink GPS Pro Imaging | Radlink, Inc. | 03/18/2025 | LLZ |
| K241937 | Klarity SGRT System (ARSG-E1A, ARSG-E3A) |
Klarity Medical & Equipment (GZ) Co., Ltd. |
03/18/2025 | IYE |
| K241783 | FortiVy™ OsteoVy™ Lumbar IBF |
Vy Spine, LLC | 03/18/2025 | MAX |
| K241729 | Hard Splint & Thermo-Adaptive Splint |
Whip Mix Corporation | 03/18/2025 | MQC |
| K240933 | CarbonCool® System | Global Healthcare SG Sdn. Bhd |
03/18/2025 | NZE |
| K240287 | LYHER® Oral Fluid Multi-Drug Test Kit (Cube) |
Hangzhou Laihe Biotech Co., Ltd. |
03/18/2025 | DJC |
| K250514 | UPT Series Medical RO Water Treatment System |
Specialty Water Technologies, Inc |
03/17/2025 | FIP |
| K250498 | BPS Wrist Fracture System | OrthoNovis, Inc. | 03/17/2025 | HRS |
| K250379 | SIGNA Prime Elite | GE Medical Systems, LLC | 03/17/2025 | LNH |
| K244056 | DOC Band 3D | Cranial Technologies, Inc. |
03/17/2025 | OAN |
| K243869 | Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 With StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0) |
The Magstim Company Limited |
03/17/2025 | OBP |
| K243867 | LAGIS Suction Irrigation System |
Lagis Enterprise Co., Ltd. |
03/17/2025 | GCJ |
| K243862 | LVivo Software Application | DiA Imaging Analysis Ltd. |
03/17/2025 | QIH |
| K243802 | Aprevo® Anterior And Lateral Lumbar Interbody Fusion Device, Aprevo® Anterior Lumbar Interbody Fusion Device With Interfixation |
Carlsmed, Inc. | 03/17/2025 | OVD |
| K243646 | Ziehm Solo FD | Ziehm Imaging GmbH | 03/17/2025 | OWB |
| K243504 | MAIA (AHMACME001) | CENTERVUE SPA | 03/17/2025 | MYC |
| K242140 | Air Compression Leg Massager (K-705) |
Jiale Health Technology Shenzhen Co., Ltd. |
03/17/2025 | IRP |
| K241975 | SERV MEDICAL CDSS | Serv Medical Pte. Ltd | 03/17/2025 | LLZ |
| K250439 | Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F; 45cm (US-34045-F-ST-H); Catapult Guide Sheath; 4F; 60cm (US-34060-F-ST-H); Catapult Guide Sheath; 4F; 90cm (US-34090-F-ST-H); Catapult Guide Sheath; 4F; 130cm (US-34130-F-ST-H); Catapult Guide Sheath; 5F; 15cm (US-35015-F-ST-H); Catapult Guide Sheath; 5F; 45cm (US-35045-F-ST-H); Catapult Guide Sheath; 5F; 45cm; Hockey Stick (US-35045-F-HS-H); Catapult Guide Sheath; 5F; 45cm; Multipurpose (US-35045-F-MP-H); Ca |
Contract Medical International GmbH |
03/16/2025 | DYB |
| K250526 | Arthrex 4.75 Mm Double Loaded Knotless Corkscrew Suture Anchor |
Arthrex, Inc. | 03/14/2025 | MAI |
| K250401 | AION TempShield™ | AION Biosystems Inc. | 03/14/2025 | FLL |
| K250267 | Visalys® Bulk Fill 1 X 4 G Syringe (15060); Visalys® Bulk Fill 15 X 0.25 G Caps (15062); Visalys® Bulk Flow 1 X 2 G Syringe (15064); Visalys® Bulk Flow 15 X 0.25 G Caps (15066); Visalys® Bulk Flow Intro Pack (15067); Visalys® Bulk Intro Pack (15068) |
Kettenbach GmbH & Co. KG | 03/14/2025 | EBF |
| K250091 | KOROT Blood Pressure Monitor (KOROT P3 Accurate) |
Korot Co. Ltd. | 03/14/2025 | DXN |
| K250079 | Ruby XL System | Penumbra, Inc. | 03/14/2025 | KRD |
| K250025 | Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Gla ze-A,Modeling Fluid ) |
Aidite (Qinhuangdao) Technology Co., Ltd. |
03/14/2025 | EIH |
| K243931 | 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 Lineage Genotyping Kit (VER 1.1 And 2); And Influenza A/H5 Subtyping Kit (VER 4) |
Centers for Disease Control and Prevention |
03/14/2025 | OZE |
| K243838 | NEXXT MATRIXX® SI System | Nexxt Spine | 03/14/2025 | OUR |
| K243599 | Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818) |
Arrow International, LLC (A Subsidiary of Teleflex, Inc.) |
03/14/2025 | FOZ |
| K243529 | Solution Administration Sets | Baxter Healthcare Corporation |
03/14/2025 | FPA |
| K243353 | One-Fil Putty | MEDICLUS CO., LTD. | 03/14/2025 | KIF |
| K243332 | Promisemed Safety Huber Needles |
Promisemed Hangzhou Meditech Co., Ltd. |
03/14/2025 | PTI |
| K242811 | BodyTom 64 | NeuroLogica Corporation, a subsidiary of Samsung |
03/14/2025 | JAK |
| K242323 | Maestro System (REF100) | Moon Surgical | 03/14/2025 | QZB |
| K242244 | Viewer+ | Lumea, Inc. | 03/14/2025 | QKQ |
| K242121 | Mbôs (Monogram Mbôs TKA System) |
Monogram Orthopaedics, Inc |
03/14/2025 | OLO |
| K242010 | Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8, SP-Y-ZQGJ3.8, SP-Y-ZQGJ4.2, SP-Y-ZQGJ4.8, SP-Y-ZQGJ5.2, SP-Y-ZQGJ5.8; Electronic Endoscope Imaging Processor: SP-TXCLQ12.1) |
Shenzhen Sanping Image Technology Co., Ltd. |
03/14/2025 | EOQ |
| K241960 | DeepRESP | Nox Medical ehf | 03/14/2025 | OLZ |
| K241816 | VerteGlide Spinal Growth Guidance System |
OrthoPediatrics Corp. | 03/14/2025 | PGM |
| K241765 | PLANET Onco Dose (3.2) | DOSIsoft SA | 03/14/2025 | LLZ |
| K234012 | VITEK COMPACT PRO | bioMerieux Inc. | 03/14/2025 | LON |
| K250385 | Turbo-Elite Laser Atherectomy Catheter |
Spectranetics | 03/13/2025 | MCW |
| K250382 | Freedom Total Knee System (All-poly Tibial Plate) |
Maxx Orthopedics, Inc. | 03/13/2025 | JWH |
| K250380 | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1) |
Surgify Medical Oy | 03/13/2025 | HBE |
| K250255 | Xvision Spine System | Augmedics Ltd. | 03/13/2025 | SBF |
| K250113 | Neolaser Laser Surgery Fibers | G.N.S neoLaser Ltd. | 03/13/2025 | GEX |
| K250088 | FlowTriever2 Catheter | Inari Medical, Inc. | 03/13/2025 | QEW |
| K244022 | 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z) |
Boston Aesthetics INC | 03/13/2025 | FTC |
| K243993 | Photon Therapy Apparatus (BL-10) |
Xemis Medical Technology (Shenzhen) Co., Ltd. |
03/13/2025 | GEX |
| K243788 | IceCap Product Line | Bioserenity Medical Devices Group |
03/13/2025 | GXY |
| K243735 | Ziehm Vision FD | Ziehm Imaging GmbH | 03/13/2025 | OWB |
| K243487 | CryoFreeze Wart And Skin Tag Remover |
CryoSurgery, Inc. | 03/13/2025 | GEH |
| K242997 | MY01 Continuous Compartmental Pressure Monitor |
MY01 Inc. | 03/13/2025 | LXC |
| K242406 | SiOxC Cream | SiOxMed, LLC | 03/13/2025 | FRO |
| K241811 | MedCAD® AccuStride™ System | MedCAD | 03/13/2025 | PBF |
| K250605 | EVOL® Ha – Hyper C Cervical Interbody Fusion System |
Cutting Edge Spine, LLC | 03/12/2025 | ODP |
| K250411 | DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System |
Dannik, LLC | 03/12/2025 | GCJ |
| K243957 | PICOALEX | WONTECH CO., LTD. | 03/12/2025 | GEX |
| K243903 | RCT600 | RAY Co., Ltd. | 03/12/2025 | OAS |
| K243849 | 2430TCA With Xmaru W | Rayence Co., Ltd | 03/12/2025 | MUE |
| K243822 | BioFire Warrior Panel; BioFire Warrior Panel Control Kit |
BioFire Defense, LLC | 03/12/2025 | PRD |
| K243783 | Walking Rehabilitation Training Electric Wheelchair (ZW518) |
Shenzhen Zuowei Technology Co., Ltd. |
03/12/2025 | IPL |
| K243763 | Wireless TENS & EMS Unit | Changsha Anxiang Medical Technology Co., Ltd. |
03/12/2025 | NGX |
| K243746 | Delphi Amplifier | QuantalX Neroscience | 03/12/2025 | GWL |
| K241822 | ReWalk® 7 Personal Exoskeleton (50-20-0005) |
ReWalk Robotics Ltd. DBA Lifeward |
03/12/2025 | PHL |
| K243029 | Origin™ TT Stem | Signature Orthopaedics Pty Ltd |
03/11/2025 | LZO |
| K242610 | 8mm Monopolar Curved Scissors (470179) |
Iconocare Health | 03/11/2025 | QSM |
