IFU is not found for this 510(k).
| 510(k) Number | Device Name | Applicant | Decision Date | Procode |
|---|---|---|---|---|
| K250689 | CloudTMS Edge | TeleEMG, LLC | 09/14/2025 | OBP |
| K251449 | BrainsWay Deep TMS System | BrainsWay Ltd. | 09/13/2025 | OBP |
| K250059 | BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O) |
Becton, Dickinson and Company |
09/12/2025 | ONB |
| K243864 | BONX805 | BONTECH Co., Ltd. | 09/12/2025 | IZL |
| K252593 | LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312) |
Boston Scientific Corporation |
09/12/2025 | MXD |
| K252562 | Spine & Trauma Navigation Instruments |
Brainlab AG | 09/12/2025 | OLO |
| K251368 | FETOLY | Diagnoly | 09/12/2025 | IYN |
| K252189 | LED Light Therapy Mask (2311, 2344, 2457, 2458) |
Dongguan Yanxi Technology Co., Ltd. |
09/12/2025 | OHS |
| K251083 | Compact II | Enraf-Nonius, B.V. | 09/12/2025 | IPF |
| K251843 | Erchonia EVRL | Erchonia Corporation | 09/12/2025 | OLP |
| K250445 | Fast Warm - NX | FUJIFILM Irvine Scientific |
09/12/2025 | MQL |
| K252027 | Vertex(TM) Catheter | Jupiter Endovascular | 09/12/2025 | DYB |
| K252225 | PowerKnot High Strength Sutures |
Medacta International S.A. |
09/12/2025 | GAT |
| K250628 | DynaNail TTC Fusion System | MedShape, Inc. | 09/12/2025 | HSB |
| K250986 | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) |
Mevion Medical Systems, Inc. |
09/12/2025 | LHN |
| K250047 | Bite Away Two | MibeTec, GmbH | 09/12/2025 | IRT |
| K252586 | CADDIE | Odin Medical Limited | 09/12/2025 | QNP |
| K252576 | Legend X Platform | Pollogen Ltd | 09/12/2025 | GEI |
| K250040 | Uws-angio | Shanghai United Imaging Healthcare Co., Ltd. |
09/12/2025 | LLZ |
| K251820 | ViewMateTM Ultrasound System | Shenzhen Mindray Bio-medical Electronics Co., Ltd. |
09/12/2025 | IYN |
| K252595 | Stethophone Pro | Sparrow Acoustics Inc. | 09/12/2025 | DQD |
| K251170 | Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter And Tangent Digital Controller |
Tangent Endoscopy LLC | 09/12/2025 | FBN |
| K252554 | Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup |
VivaChek Biotech (Hangzhou) Co., Ltd |
09/12/2025 | NFT |
| K251518 | Volta AF-Xplorer II | Volta Medical | 09/12/2025 | DQK |
| K250507 | Hypertension Notification Feature (HTNF) |
Apple Inc. | 09/11/2025 | SFR |
| K250216 | OsteoProbe (OP-100) | Active Life Scientific, Inc. |
09/11/2025 | QGQ |
| K252374 | Nylon Flextap(r) | Airway Technologies d/b/a Airway Management |
09/11/2025 | LRK |
| K251320 | XTRA4 | AL.CHI.MI.A. S.r.l | 09/11/2025 | LYX |
| K242314 | Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2) |
Augment Intelligent Medical System (China) Co., Ltd. |
09/11/2025 | LLZ |
| K251158 | PowerWire® 14 Radiofrequency Guidewire Kit |
Baylis Medical Technologies Inc. |
09/11/2025 | PDU |
| K243926 | Vivatmo Pro-s | Bosch Healthcare Solutions GmbH |
09/11/2025 | MXA |
| K251399 | SIGNA™ Sprint | GE Medical Systems, LLC | 09/11/2025 | LNH |
| K252520 | SEFRIA™ Hydrocodone Oral Fluid |
Immunalysis Corporation | 09/11/2025 | DJG |
| K251316 | Mazor X System / Mazor X Stealth Edition |
Mazor Robotics Ltd. | 09/11/2025 | OLO |
| K251826 | RENASYS WOUND+ Dressing Kit With AIRLOCK Technology |
Smith & Nephew Medical Ltd |
09/11/2025 | OMP |
| K251758 | Serafin® | TNS Co., Ltd. | 09/11/2025 | NXC |
| K250797 | UV5000 Handle | UroViu Corporation | 09/11/2025 | FAJ |
| K244002 | AngioWaveNet | Angiowave Imaging, Inc. | 09/10/2025 | QIH |
| K252580 | Iq200 Series | Beckman Coulter, Inc | 09/10/2025 | LKM |
| K252173 | F&P OptiNIV Hospital Vented Full Face Mask Compatible With Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible With Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible With Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask With Optional Expiratory Filter Compatible With Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full |
Fisher & Paykel Healthcare Ltd |
09/10/2025 | CBK |
| K251817 | Da Vinci SP Surgical System (SP1098) |
Intuitive Surgical Inc. | 09/10/2025 | NAY |
| K252527 | Surfacer Inside-Out Access Catheter System |
Merit Medical System Inc. |
09/10/2025 | QJH |
| K252530 | OptiVu™ Shoulder | MR Surgical Solutions, LLC |
09/10/2025 | SBF |
| K250734 | OptiLUV Device | Pollogen Ltd. | 09/10/2025 | PBX |
| K250464 | Enlight 2100 (TPL-E2103-0) | Timpel S.A. | 09/10/2025 | |
| K251573 | VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens |
VIZIONFOCUS INC. | 09/10/2025 | LPL |
| K243846 | Access Anti-hav | Beckman Coulter Inc. | 09/09/2025 | LOL |
| K250922 | Edema Guard Monitor (EGM) CardioSet-001 |
CardioSet Medical Ltd. | 09/09/2025 | DSB |
| K251072 | Segmentron Viewer | DGNCT, LLC | 09/09/2025 | QIH |
| K252524 | Quadsense (Quadsense And Quadsense Pro) |
Eventum Orthopaedics Ltd | 09/09/2025 | ONN |
| K252181 | AquaA | Fresenius Medical Care North America |
09/09/2025 | FIP |
| K252180 | Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W) |
Fresenius Medical Care Renal Therapies Group, LLC |
09/09/2025 | KPO |
| K251040 | MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test |
Guangzhou Decheng Biotechnology Co., Ltd. |
09/09/2025 | LCX |
| K252477 | Hybrid Viewer (00859873006240) | Hermes Medical Solutions AB |
09/09/2025 | KPS |
| K251891 | Electric Wheelchair (GY-E001) | Shandong Guyue Healthcare Appliance Co., Ltd. |
09/09/2025 | ITI |
| K251773 | Water-soluble Personal Lubricant (Satin Gel Vitamin E Flavor Lubricant; Satin Gel Caramel Flavor Lubricant; Satin Gel Peach Flavor Lubricant; Satin Gel Strawberry Flavor Lubricant.) |
Shenzhen Yongquan Medical Devices Co., Ltd. |
09/09/2025 | NUC |
| K252608 | AI-Rad Companion Prostate MR | Siemens Healthcare GmbH | 09/09/2025 | LLZ |
| K251682 | MuscleView 2.0 | Springbok, Inc. (dba Springbok Analytics) |
09/09/2025 | LNH |
| K250483 | PhotonBlade 3; PhotonBlade 3 Smoke Evacuation |
Stryker Instruments | 09/09/2025 | GEI |
| K251227 | Da Vinci Surgical System (IS5000) |
Intuitive Surgical, Inc. | 09/08/2025 | NAY |
| K251892 | MAXXOS P.A.C.E. Foot & Ankle Plating System |
MAXXOS Medical GmbH | 09/08/2025 | HRS |
| K250229 | Dual Action Tissue Closure Device |
Micro-Tech (Nanjing) Co., Ltd |
09/08/2025 | PKL |
| K250928 | OmniTom Elite With PCD | NeuroLogica Corporation | 09/08/2025 | JAK |
| K251610 | Qer-cta (v1.0) | Qure.ai Technologies | 09/08/2025 | QAS |
| K250960 | DUO Microcatheter | REV Neuro LLC | 09/08/2025 | QJP |
| K251394 | Momcozy Wearable Breast Pump (BP223) |
Shenzhen Root Innovation Technology Co., Ltd. |
09/08/2025 | HGX |
| K251754 | Wearable Breast Pump (Model S33) |
Shenzhen TPH Technology Co., Ltd. |
09/08/2025 | HGX |
| K251931 | BioTraceIO Vision (V1.7) | Techsomed Medical Technologies |
09/08/2025 | QTZ |
| K251957 | Coaptium Connect With Tissium Light |
TISSIUM SA | 09/08/2025 | SFD |
| K251022 | 3D-SHAPER | 3D-SHAPER MEDICAL S.L | 09/05/2025 | KGI |
| K252478 | Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ Duo M.R.I. ™ Implantable Port |
Bard Access Systems, Inc. |
09/05/2025 | LJT |
| K251753 | GenaCheck COVID-19 Rapid Self-Test |
Genabio Diagnostics Inc | 09/05/2025 | QYT |
| K251317 | SOLOPASS 2.0 System | inTRAvent Medical Partners |
09/05/2025 | HAW |
| K252528 | Ion Endoluminal System (IF1000) |
Intuitive Surgical Inc. | 09/05/2025 | EOQ |
| K250460 | WatchPAT400 (WP400) | Itamar Medical Ltd. | 09/05/2025 | MNR |
| K243795 | Preboa-pro Catheter | Prytime Medical Devices, Inc. |
09/05/2025 | MJN |
| K244038 | High Pressure Tubing | Shandong INT Medical Instruments Co., Ltd. |
09/05/2025 | DXT |
| K251250 | ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System (VMM-ICE-02) |
Shenzhen Mindray Bio-medical Electronics Co., Ltd. |
09/05/2025 | IYN |
| K250095 | All-Suture Dual Anchor System | SutureTech, Inc. | 09/05/2025 | MBI |
| K250575 | The Sensititre 18 - 24 Hour MIC Or Breakpoint Susceptibility System With Aztreonam/avibactam In The Dilution Range Of 0.008/4 - 64/4 Ug/ml |
Thermofisher Scientific | 09/05/2025 | JWY |
| K250132 | Ureteral Access Sheath | Zhejiang YiGao Medical Technology Co., Ltd. |
09/05/2025 | FED |
| K251463 | EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01) |
Abbott Medical | 09/04/2025 | DQK |
| K250893 | Ball Joint Guide Array (66295) | Bayer Medical Care, Inc. | 09/04/2025 | HAW |
| K251168 | Image Suite | Carestream Health Inc. | 09/04/2025 | LLZ |
| K251656 | Careverse CoronaryDoc (Careverse CoronaryDoc) |
Careverse Technology Pte. Ltd. |
09/04/2025 | QIH |
| K251298 | Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6) |
Clinical Laserthermia Systems AB |
09/04/2025 | ONO |
| K251438 | Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) |
Guilin Woodpecker Medical Instrument Co., Ltd. |
09/04/2025 | EHD |
| K251533 | Rapid Obstructive Hydrocephalus, Rapid OH |
iSchemaView Inc. | 09/04/2025 | QAS |
| K243700 | Apollo TMS Therapy System | MAG & More GmbH | 09/04/2025 | OBP |
| K251737 | NextAR(TM) Shoulder Platform | Medacta International S.A. |
09/04/2025 | SBF |
| K251510 | Symani Surgical System | Medical Microinstruments, Inc. |
09/04/2025 | SAQ |
| K251444 | Endoskeleton™ Interbody Systems |
Medtronic Sofamor Danek USA, Inc. |
09/04/2025 | MAX |
| K251545 | Intense Pulsed Light Therapy Device (MMABM-1) |
Micowey Medical Equipment (Guangxi) Co., LTD |
09/04/2025 | ONF |
| K243789 | LIBERTY Endovascular Robotic System (LIBERTYOS) |
Microbot Medical Ltd. | 09/04/2025 | DXX |
| K250064 | Dose+ (1.0) | Mvision AI Oy | 09/04/2025 | MUJ |
| K250353 | Oniris; Oniris Plus | Oniris | 09/04/2025 | LRK |
| K250770 | Optina-4C (MHRC-C1N) | Optina Diagnostics Inc. | 09/04/2025 | HKI |
| K251781 | KALA MINI 2.0 (KALA-04) | Shenzhen Kaiyan Medical Equipment Co., Ltd. |
09/04/2025 | OHS |
| K251733 | Fluido® AirGuard System | The Surgical Company International BV (as TSC Life) |
09/04/2025 | LGZ |
| K251909 | NeurotriS (SX2500); NeurotriS (SX3800) |
A-1 Engineering | 09/03/2025 | NFO |
| K250217 | AGNES Ultra | Agnes Medical Co., Ltd | 09/03/2025 | GEI |
| K251575 | IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System |
Alphatec Spine | 09/03/2025 | OVD |
| K252539 | Tempus Pixel | Arterys, Inc. | 09/03/2025 | QIH |
| K250765 | AViTA Arm Type Blood Pressure Monitor Cuff |
AViTA Corporation | 09/03/2025 | DXQ |
| K251457 | Diode Laser Therapy Device (VADER) |
Beijing Superlaser Technology Co., Ltd. |
09/03/2025 | GEX |
| K252174 | AquaCast Mask | Blessing Cathay Corporation |
09/03/2025 | IYE |
| K250231 | Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X, BA-845X, BA-847X, BA-849X, BA-851X, BA-852X, BA-855X, BA-835, BA-836, BA-839, BA-840, BA-856) |
DONGGUAN E-TEST TECHNOLOGY CO., LTD |
09/03/2025 | DXN |
| K251726 | SignalNED System (Model RE) | Forest Devices, Inc | 09/03/2025 | OMC |
| K231952 | MEDILIGHT | Medicreations LLC | 09/03/2025 | ONF |
| K252446 | BruxZir® NOW | Prismatik Dentalcraft, Inc. |
09/03/2025 | EIH |
| K252454 | Kinos Total Ankle System | restor3d | 09/03/2025 | HSN |
| K251615 | Aerogen Pro-X1 Controller System |
Aerogen Ltd | 09/02/2025 | SFP |
| K251775 | RODIN Cement | Belport Company, Inc., Gingi-Pak |
09/02/2025 | EMA |
| K242768 | Customized Abutment And Screw | Chengdu Besmile Medical Technology Co., Ltd. |
09/02/2025 | NHA |
| K251975 | Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component |
Ignite OrthoMotion | 09/02/2025 | NJD |
| K251408 | OsteoSight™ Hip (v1) | Naitive Technologies Ltd | 09/02/2025 | SAO |
| K250453 | IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500) |
Philips Medizin Systeme Böblingen GmbH |
09/02/2025 | MHX |
| K250753 | VELMENI For DENTISTS (V4D) | Velmeni Inc. | 09/02/2025 | MYN |
| K252019 | CurvaFix Low Profile System | CurvaFix, Inc. | 08/29/2025 | HWC |
| K252380 | Invisalign System | Align Technology, Inc | 08/29/2025 | NXC |
| K243799 | Fetal Pillow | CooperSurgical Inc., | 08/29/2025 | PWB |
| K250771 | Primescan 2 | Dentsply Sirona Inc. | 08/29/2025 | NTK |
| K252364 | Edwards Esheath Optima Introducer Set |
Edwards Lifesciences | 08/29/2025 | DYB |
| K251814 | EZ™ IV Administration Set | Epic Medical Pte. Ltd. | 08/29/2025 | FPA |
| K251108 | Erbe ESU Model VIO® 3n With Accessories |
Erbe Elektromedizin GmbH | 08/29/2025 | GEI |
| K251106 | Sonosite LX And Sonosite PX Ultrasound Systems |
Fujifilm Sonosite Inc | 08/29/2025 | IYN |
| K243745 | FG Bone Graft B | Full Golden Biotech Corporation |
08/29/2025 | LYC |
| K251946 | G Aenial Universal Injectable II |
GC America, Inc. | 08/29/2025 | EBF |
| K250003 | GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) |
Geneseeq Technology Inc. | 08/29/2025 | PZM |
| K251324 | Da Vinci SP Surgical System (SP1098) |
Intuitive Surgical, Inc. | 08/29/2025 | NAY |
| K250335 | IVA & AEON Cervical And Lumbar Cage System |
K&J Consulting | 08/29/2025 | ODP |
| K251718 | ArTT Augments And Buttresses And Bone Screws |
Limacorporate S.p.A. | 08/29/2025 | |
| K251217 | SmartGuard Technology; Predictive Low Glucose Technology |
Medtronic MiniMed Inc | 08/29/2025 | QJI |
| K251181 | Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guide Wire (MSWSTD35260J1O5); Splashwire Hydrophilic Guide Wire (MSWSTDA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35260LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFS38150LT) |
Merit Medical Ireland Ltd., |
08/29/2025 | DQX |
| K251480 | PV01 PVDF Effort Sensor | Neurotronics, LLC | 08/29/2025 | SFK |
| K243859 | PRAEVAorta®2 | Nurea | 08/29/2025 | QIH |
| K252392 | Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set |
Perfuze Ltd | 08/29/2025 | NRY |
| K250939 | SIRIUS Endoscope System (PR-SI-1230) |
Precision Robotics (Hong Kong) Limited |
08/29/2025 | HET |
| K250285 | NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOL |
RAUMEDIC AG | 08/29/2025 | GWM |
| K250874 | Sunrise | Sunrise SA | 08/29/2025 | QRS |
| K251727 | GLAM LED Facial Mask (TB-2386F) |
TOUCHBEAUTY BEAUTY & HEALTH (SHENZHEN) CO., LTD |
08/29/2025 | GEX |
| K251026 | Regenesis EMS Chair | Trinity Medical Solutions |
08/29/2025 | KPI |
| K250290 | SurgiTwin | Twinsight | 08/29/2025 | LLZ |
| K251429 | OTC 4-Channel Rechargeable TENS Unit |
Changsha Anxiang Medical Technology Co., Ltd |
08/28/2025 | NUH |
| K251484 | CT:VQ | 4DMedical Limited | 08/28/2025 | JAK |
| K251965 | Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) |
Alphatec Spine, Inc. | 08/28/2025 | KWQ |
| K252505 | Powder-Free Vinyl Exam Gloves, Clear |
Basic Medical Technology Inc. |
08/28/2025 | LYZ |
| K252383 | Somfit D | Compumedics Limited | 08/28/2025 | MNR |
| K252030 | RadiForce GX570; RadiForce GX570-AR |
EIZO Corporation | 08/28/2025 | PGY |
| K252411 | JARVIS Glenoid Reverse Shoulder Prosthesis |
FH Industrie | 08/28/2025 | PHX |
| K250788 | Definium Tempo Select | GE Hualun Medical Systems Co., Ltd |
08/28/2025 | KPR |
| K252057 | Symphony™ Thrombectomy System And Symphony™ 16F 82cm Thrombectomy System |
Imperative Care, Inc. | 08/28/2025 | QEW |
| K252437 | JAZZ Spinal System | Implanet | 08/28/2025 | NKB |
| K252350 | Da Vinci SP Firefly Imaging System |
Intuitive Surgical, Inc. | 08/28/2025 | NAY |
| K250148 | Medical Gas Analyzer (AG200) | Prior Care Science Technology LTD |
08/28/2025 | CCK |
| K243767 | SV600, SV800 Ventilator | Shenzhen Mindray Bio-medical Electronics Co., LTD. |
08/28/2025 | CBK |
| K251594 | Truflex | Syrma Johari Medtech Limited |
08/28/2025 | NGX |
| K252014 | The Sensititre 18-24 Hour MIC Or Breakpoint Susceptibility System With Amikacin In The Dilution Range Of 0.25-256 Ug/ml |
Thermo Fisher Scientific | 08/28/2025 | JWY |
| K243901 | SmartPilot YpsoMate NS-A2.25 | Ypsomed AG | 08/28/2025 | QOG |
| K251415 | Additively Manufactured Aligner Resin |
Aidite (Qinhuangdao) Technology Co., Ltd. |
08/27/2025 | NXC |
| K251382 | Phoenix Sinus Tarsi Stent System |
Astra OrthoMed, Inc. | 08/27/2025 | HWC |
| K252419 | HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) |
Atraverse Medical, Inc. | 08/27/2025 | DXF |
| K251716 | Nitrile Powder-Free Exam Gloves Tested For Use With Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid And Xylazine In Fentanyl Citrate |
Basic Medical Technology Inc. |
08/27/2025 | LZA |
| K251637 | Dewin Reproductive Media (Dewin Gamete Buffer [with HSA And Without HSA]; Dewin Follicle Flushing Solution, Dewin One Step Medium [with HSA And Without HSA]) |
DonneVie Medical Technology (Shanghai) Co. Ltd. |
08/27/2025 | MQL |
| K250947 | VistaSoft 4.0 And VisionX 4.0 | DURR DENTAL SE | 08/27/2025 | QIH |
| K241882 | Fetal & Maternal Monitor (F15A, F15A Air) |
Edan Instruments Inc. | 08/27/2025 | HGM |
| K241766 | QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) |
Fysicon BV | 08/27/2025 | MWI |
| K252118 | CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup |
Hangzhou Clongene Biotech Co.,Ltd. |
08/27/2025 | NFT |
| K243166 | Dermalage | Infection Elimination Solutions, LLC |
08/27/2025 | FRO |
| K243774 | ELID (Endoscopic Less Invasive Decompression) System |
LESspine Innovations | 08/27/2025 | HRX |
| K250625 | Portable Oxygen Concentrator (W-R1(MAX)); Portable Oxygen Concentrator (W-R1); Portable Oxygen Concentrator (W-R2); Portable Oxygen Concentrator (W-R2(Lite)) |
Nanjing Yinuoji Medical Technology Co., Ltd. |
08/27/2025 | CAW |
| K243687 | Vital Signs | Oxehealth Limited | 08/27/2025 | QME |
| K250080 | QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini |
Qiagen GmbH | 08/27/2025 | QOF |
| K251752 | Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US) |
Shanghai AnQing Medical Instrument Co., Ltd. |
08/27/2025 | EOQ |
| K251068 | KnoxFog Anti-fogging Device | UV One Hygienics, Inc. | 08/27/2025 | OCT |
| K251983 | Brainomix 360 Triage Stroke | Brainomix Limited | 08/26/2025 | QAS |
| K250261 | Heager Medical Laser Family (Sabrina/Adolf) |
Heager Gmbh | 08/26/2025 | GEX |
| K244061 | X-Wire Guidewire | Imperative Care, Inc. | 08/26/2025 | MOF |
| K252526 | Rapid DeltaFuse | iSchemaView Inc. | 08/26/2025 | LLZ |
| K251305 | Ultra-Fast Vitri; Ultra-Fast Warm |
Kitazato Corporation | 08/26/2025 | MQL |
| K250049 | Medical Video Endoscope [Standard Deflection] (URS3005); Medical Video Endoscope [Reverse Deflection] (URS3005E); Medical Video Endoscope [Standard Deflection] (URS3006); Medical Video Endoscope [Reverse Deflection] (URS3006E); Medical Video Endoscope [Standard Deflection] (URS3016); Medical Video Endoscope [Reverse Deflection] (URS3016E); Image Processor (DIS8000) |
Seplou (ZHUHAI) Co., Ltd. |
08/26/2025 | FGB |
| K251593 | DenMat Multilayered Zirconia Disc |
DenMat Holding, LLC | 08/25/2025 | EIH |
| K251811 | Motor And Apex Module (MaAM) | Dentsply Sirona Inc. | 08/25/2025 | EBW |
| K243800 | PRO Pen Microneedling System (6883) |
Dermalogica, LLC | 08/25/2025 | QAI |
| K251404 | Quantra QStat Cartridge | HemoSonics LLC | 08/25/2025 | QFR |
| K243634 | Maxx Libertas Bipolar Hip Head (Bipolar Hip) |
Maxx Orthopedics, Inc. | 08/25/2025 | KWY |
| K243709 | NeuroEars-Anna™ | NeuroEars Inc. | 08/25/2025 | GWN |
| K243834 | NobelZygoma TiUltra Implant System |
Nobel Biocare AB | 08/25/2025 | DZE |
| K243680 | Neurovascular Insight V1.0 | Olea Medical S.A.S. | 08/25/2025 | LLZ |
| K251440 | CRYOcheck Chromogenic Factor VIII |
Precision BioLogic Inc. | 08/25/2025 | GGP |
| K251246 | Sparrow Ascent | Spark Biomedical, Inc. | 08/25/2025 | PZR |
| 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 |
| K251877 | JMS CAVEO A.V. Fistula Needle Set |
JMS North America Corporation |
08/15/2025 | FIE |
| 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 |
| 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 |
| 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 |
| K251713 | BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 Μg/ml) |
Becton, Dickinson and Company |
08/08/2025 | LON |
| 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 | JWO |
| 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 |
| K250508 | AK 98 Dialysis Machine (955607) |
Vantive US Healthcare LLC |
08/01/2025 | KDI |
| K251707 | IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L) |
Shenzhen Huachuangtong Industrial Co., Ltd. |
08/01/2025 | OHT |
| K251252 | NOBILCAM IMPAK Disc | Shandong Huge Dental Material Corporation |
08/01/2025 | MQC |
| K243496 | MycoMEIA Aspergillus Assay | Pearl Diagnostics, Inc. | 08/01/2025 | NOM |
| K250541 | Self-Forming Magnet (Flexagon Plus OTOLoc) |
GI Windows, Inc. | 08/01/2025 | SAH |
| K250941 | Revolution Vibe | GE Medical Systems, LLC | 08/01/2025 | JAK |
| K243448 | Equinoxe® Shoulder System | Exactech Inc. | 08/01/2025 | PHX |
| K252094 | Ezsure™ Empty Fluid Container |
Epic Medical Pte. Ltd. | 08/01/2025 | KPE |
| K250790 | INNOVISION-DXII | DK MEDICAL SYSTEMS Co., Ltd |
08/01/2025 | KPR |
| K243462 | Diazyme Colorimetric Lithium Assay |
Diazyme Laboratories, Inc. |
08/01/2025 | NDW |
| K243427 | QuickSleeper 5 | Dentalhitec | 08/01/2025 | EGM |
| K243841 | Sparta Infusion Set For Insulin |
DEKA Research and Development |
08/01/2025 | FPA |
| K250381 | Deepsight NeedleVue LC1 Ultrasound System |
DeepSight Technology, Inc. |
08/01/2025 | IYO |
| K243483 | Access Hstni | Beckman Coulter Inc. | 08/01/2025 | MMI |
| K250495 | MINI VP1 (PL67_F); MINI VP1 (PL61_F) |
Avizor S.A. | 08/01/2025 | LRX |
| 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 |
| K250315 | RONAVIS – FX (FX-001) | AIRS Inc. | 08/01/2025 | HTY |
| 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 |
| 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 |
