IFU is not found for this 510(k).
| 510(k) Number | Device Name | Applicant | Decision Date | Procode |
|---|---|---|---|---|
| K250178 | Adin Customized Abutments | Adin Dental Implant Systems Ltd. |
10/17/2025 | NHA |
| K250197 | Estremo Fibular Nail | Citieffe s.r.l. | 10/17/2025 | HSB |
| K250911 | MOSkin Radiation Measurement System |
Electrogenics Labs, Ltd | 10/17/2025 | IYE |
| K250145 | Biopsy Port Adapter | EndoSound, Inc. | 10/17/2025 | ODC |
| K251282 | StealthStation S8 Spine Software |
Medtronic Navigation, Inc. |
10/17/2025 | OLO |
| K250945 | Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series) |
Olympus Medical Systems Corp. |
10/17/2025 | KNS |
| K251146 | IntelliVue Patient Monitors MX400, MX450, MX500, MX550 |
Philips Medizin Systeme Boeblingen GmbH |
10/17/2025 | MHX |
| K252075 | Program Insite® Powder-Free, Disposable Nitrile Exam Gloves |
Program insite LLC | 10/17/2025 | LZA |
| K251778 | Remi Custom Night Guard | Remi | 10/17/2025 | OBR |
| K252266 | S.I.N. Dental Implant System | S.I.N. Implant System LTDA. |
10/17/2025 | NHA |
| K250227 | JOVS Electric Stimulation Beauty Device (JE2) |
Shenzhen Qianyu Technology Co., Ltd. |
10/17/2025 | NFO |
| K252264 | MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3, JML3+JML4); MEGELIN LED Light Therapy Mask (JML5, JML5+JML7); MEGELIN LED Light Therapy Mask (JML6, JML6+JML8); MEGELIN LED Light Therapy Mask (JML9, JML9+JML10) |
Shenzhen Zhenxing Ruitong Technology Co., Ltd. |
10/17/2025 | OHS |
| K250250 | ADVIA Centaur Anti-Thyroid Peroxidase II |
Siemens Healthcare Diagnostics, Inc. |
10/17/2025 | JZO |
| K252254 | Osteotomy Wedge System | SiNAPTIC Surgical | 10/17/2025 | PLF |
| K251355 | X1-FFR | SpectraWAVE, Inc. | 10/17/2025 | QHA |
| K251832 | InZone IST Detachment System; IZDS Connecting Cable |
Stryker Neurovascular | 10/17/2025 | HCG |
| K250203 | SureAx-Guide™ | SureAx Medical, LLC | 10/17/2025 | DQX |
| K250159 | Immunoglobulin Isotypes (GAM) For The EXENT Analyser; EXENT Analyser |
The Binding Site Group Ltd |
10/17/2025 | CFN |
| K251673 | X9 Ultrasound System | X9, Inc. | 10/17/2025 | SGH |
| K251994 | Arthrex Synergy Vision Imaging System |
Arthrex, Inc. | 10/16/2025 | GCJ |
| K250852 | Coolfase | ASTERASYS Co., Ltd. | 10/16/2025 | GEI |
| K252476 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout |
Brainlab AG | 10/16/2025 | LLZ |
| K252631 | Profoject™ Disposable Needle | CMT Health PTE. Ltd. | 10/16/2025 | FMI |
| K253000 | CryoFreeze Wart And Skin Tag Remover |
CryoSurgery, Inc. | 10/16/2025 | GEH |
| K251497 | Elos Accurate Hybrid Base | Elos Medtech Pinol A/S | 10/16/2025 | NHA |
| K251882 | Uterine Aspiration Set | GCMEDICA ENTERPRISE LTD.(WUXI) |
10/16/2025 | HHK |
| K250731 | MateLaser Medical Diode Laser Systems (ML-DLS-30) |
MateLaser, Inc. | 10/16/2025 | NVK |
| K242100 | SurgiAid Collagen Wound Dressing (HA) |
Maxigen Biotech Inc. | 10/16/2025 | KGN |
| K252093 | Light Therapy Mask (1019055) | Merchsource LLC | 10/16/2025 | OHS |
| K243727 | Re:Balans | Mode Sensors AS | 10/16/2025 | DSB |
| K252024 | NeurAxis IB-Stim (01-1020) | NeurAxis | 10/16/2025 | QHH |
| K252247 | Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L) |
Olympus Medical Systems Corporation |
10/16/2025 | FBK |
| K252612 | INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing |
Penumbra, Inc. | 10/16/2025 | QEW |
| K253114 | TargetCool™ (RM-DT02W) | RecensMedical Inc. | 10/16/2025 | GEH |
| K253024 | ProZip Knotless Implant | Riverpoint Medical | 10/16/2025 | GAT |
| K252153 | FFX Facet Fixation System | SC Medica | 10/16/2025 | MRW |
| K252223 | Alpha Endo Handpiece (Alpha Endo) |
Shenzhen Superline Technology Co., Ltd. |
10/16/2025 | EKX |
| K252199 | AGFA HealthCare Enterprise Imaging |
AGFA HealthCare N.V. | 10/15/2025 | LLZ |
| K252946 | BioBrace® Extra-Articular Ligament Augmentation Kit |
CONMED Corporation | 10/15/2025 | MAI |
| K250107 | V-soft Line™ Barbed Surgical Suture (Various) |
Feeltech Co., Ltd | 10/15/2025 | NEW |
| K252020 | TunnelVision Endoscopic Soft Tissue Release System And The HBL Blade Assembly |
Hand Biomechanics Lab, Inc. |
10/15/2025 | |
| K252367 | InbellaMulti System | Inbella Medical Inc. | 10/15/2025 | GEI |
| K252920 | ELEOS™ Limb Salvage System With NanoCept® Technology |
Onkos Surgical, Inc. | 10/15/2025 | QZZ |
| K253348 | TargetCool-e | RecensMedical, Inc. | 10/15/2025 | GEH |
| K250510 | Sure-Fine Insulin Syringes | SHINA MED CORPORATION | 10/15/2025 | FMF |
| K251805 | Syngo.ct Dual Energy | Siemens Medical Solutions USA, Inc. |
10/15/2025 | JAK |
| K251294 | Bonafix Implant Abutments | Zentek Medical LLC | 10/15/2025 | NHA |
| K252944 | LOCATOR® Angled Abutment | Zest Anchors, LLC | 10/15/2025 | NHA |
| K250979 | Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad) |
ZOLL Circulation, Inc | 10/15/2025 | NZE |
| K251715 | FlowArt® Vial Access Device Vented |
Asset Medikal | 10/14/2025 | LHI |
| K250776 | Lithoblast Single Use Holmium Laser Fibers |
Dawell Medical LLC. | 10/14/2025 | GEX |
| K252637 | Community Containers (Flap And Daisy) |
Keter Canada, Inc. | 10/14/2025 | MMK |
| K253461 | Demi Pro | Meta Systems Co., Ltd. | 10/14/2025 | EBZ |
| K253331 | PressON Spinal Fixation System | Nexus Spine | 10/14/2025 | NKB |
| K253099 | LIFEPAK 15 AC Power Adapter (41577-000333) |
Physio-Control, Inc. | 10/14/2025 | MPD |
| K251874 | PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013) |
PureWay Compliance Inc. | 10/14/2025 | MMK |
| K250115 | Hemastyl(™) Wound Dressing | Rapid Nexus Nanotech Wound Solutions, Inc. |
10/14/2025 | FRO |
| K253010 | Mini Superhawk Suture Anchor System |
Responsive Arthroscopy, LLC |
10/14/2025 | MBI |
| K252234 | IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13, FDA14, FDA15, FDA16, FDA17, FDA18, FDA19, FDA20, FDA21S, FDA22S, FDA23S, FDA24S, FDA25, FDA26, FDA27, FDA28, FDA29S, FDA30S, FDA31S) |
Shenzhen Qiaochengli Technology Co., Ltd |
10/14/2025 | OHT |
| K251522 | Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ |
Bone Solutions, Inc. | 10/13/2025 | MQV |
| K251595 | COVID-19 Detect Rapid Self -Test |
InBios International, Inc. |
10/12/2025 | QYT |
| K242227 | GENEO X ELITE | Pollogen, Ltd. | 10/12/2025 | PAY |
| K251034 | Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare Wand (HD-44) |
Shenzhen Nuon Medical Equipment Co., Ltd |
10/12/2025 | NFO |
| K250085 | On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System |
ACON Laboratories, Inc. | 10/10/2025 | NBW |
| K251602 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 With Aevolve Imaging |
Canon Medical Systems Corporation |
10/10/2025 | OWB |
| K252903 | Verruca-Freeze H Plus | CryoSurgery, Inc. | 10/10/2025 | GEH |
| K252737 | DeGen Medical Latitude-C AM Cervical Interbody Fusion System |
DeGen Medical | 10/10/2025 | ODP |
| K252312 | Eleganz IM Threaded Nail System (IM Threaded Nail System) |
Dev4 | 10/10/2025 | HWC |
| K251708 | EvoEndo Single-Use Endoscopy System |
EvoEndo, Inc. | 10/10/2025 | FDS |
| K252209 | IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032) |
Foshan Jindi Electric Appliance Co., Ltd |
10/10/2025 | OHT |
| K250249 | Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System |
Gold Standard Diagnostics, LLC. |
10/10/2025 | GMQ |
| K251835 | Yomi Robotic System | Neocis, Inc. | 10/10/2025 | PLV |
| K250351 | Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U) |
Olympus Medical Systems Corporation |
10/10/2025 | KNS |
| K243078 | HexaPLUS S OneDrill Implant System |
Osseofuse International Inc. |
10/10/2025 | DZE |
| K251082 | HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) |
Procept BioRobotics | 10/10/2025 | PZP |
| K243815 | SoClean 3+ | SoClean, Inc. | 10/10/2025 | QXQ |
| K251866 | Tegaderm Post-Op Transparent Antimicrobial Dressing |
Solventum US, LLC | 10/10/2025 | FRO |
| K252544 | TMINI Miniature Robotic System | Think Surgical, Inc. | 10/10/2025 | OLO |
| K252001 | Collagen Wound Dressing | Winner Medical Co., Ltd. | 10/10/2025 | KGN |
| K251927 | Zeta Navigation System (ZNS131-US) |
Zeta Surgical Inc. | 10/10/2025 | SGE |
| K252867 | VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup |
Advin Biotech, Inc. | 10/09/2025 | NFT |
| K252870 | Invisalign Specifix Attachment System |
Align Technology, Inc. | 10/09/2025 | NXC |
| K252910 | Orca Air/Water And Suction Valves |
Boston Scientific | 10/09/2025 | ODC |
| K252939 | COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS |
Cotton High Tech S.L. | 10/09/2025 | HEB |
| K251851 | DIASAFEplusUS (F00013010) | Fresenius Medical Care Renal Therapies Group, LLC |
10/09/2025 | FIP |
| K250645 | SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002) |
Haemoband Surgical LTD | 10/09/2025 | FER |
| K251795 | Wrist Automatic Blood Pressure Monitor (LD-735, LD-752, LD-753) |
HONSUN (Nantong) Co.,Ltd. |
10/09/2025 | DXN |
| K252911 | Lux HD 2530 Detector (Lux HD 2530) |
iRay Imaging Technology (Haining) Limited |
10/09/2025 | MQB |
| K251366 | EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A) |
Nihon Kohden Corporation | 10/09/2025 | OLT |
| K251876 | Cleadew GP Hydra One | Ophtecs Corporation | 10/09/2025 | MRC |
| K252600 | Pediatric Plating Platform I Small-Mini |
OrthoPediatrics Corp. | 10/09/2025 | HRS |
| K251651 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System |
Philips Ultrasound LLC | 10/09/2025 | IYN |
| K252553 | Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507) |
Shenzhen Jianchao Intelligent Technology Co., LTD |
10/09/2025 | NFO |
| K252272 | ORA Method LED Gua Sha (GS-04) | Shenzhen Kaiyan Medical Equipment Co., Ltd |
10/09/2025 | OHS |
| K253094 | Ifuse Bedrock Granite Implant System |
SI-Bone, Inc. | 10/09/2025 | OUR |
| K252766 | 14Fr Low Profile Introducer Kit |
Abiomed Inc. | 10/08/2025 | DYB |
| K251422 | BD Saf-T-Intima™ Subcutaneous Catheter System |
Becton Dickinson Infusion Therapy Systems Inc. |
10/08/2025 | FOZ |
| K251699 | The Botticelli (Model: Athena) | Bellamia Technologies, Inc. |
10/08/2025 | GEX |
| K250298 | Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® With Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® For Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S) |
Clinical Innovations, LLC |
10/08/2025 | HDB |
| K251363 | ProKnow DS | Elekta Solutions AB | 10/08/2025 | LLZ |
| K250536 | MetaFore Small Screw System | Extremity Medical, LLC | 10/08/2025 | HWC |
| K250060 | GT300; GT300-C | GENORAY CO., LTD. | 10/08/2025 | OAS |
| K251162 | CUSA® Clarity Ultrasonic Surgical Aspirator System |
Integra LifeSciences Corporation |
10/08/2025 | LFL |
| K252163 | Elecsys Phospho-Tau (181P) Plasma |
Roche Diagnostics | 10/08/2025 | SET |
| K252874 | Compass Steerable Needle With Adapters SRA-1-01 And SRA-2-01 |
Serpex Medical, Inc. | 10/08/2025 | KTI |
| K250688 | Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar™ Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US) |
Acotec Scientific Co., Ltd. |
10/07/2025 | GEI |
| K252851 | Deeplive (OSP12 + DMS) | DAMAE Medical | 10/07/2025 | NQQ |
| K250894 | Eminent Spine Posterior SI System |
Eminent Spine | 10/07/2025 | OUR |
| K252214 | AIAS Cephalon | metamorphosis GmbH | 10/07/2025 | QIH |
| K250187 | Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) |
Olympus Medical Systems Corporation |
10/07/2025 | KGE |
| K252150 | Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shears With Ultrasonic Mode, 5mm, 45cm (TB2-0545FC); THUNDERBEAT II Shears With Ultrasonic Mode, 5mm, 35cm (TB2-0535FC); THUNDERBEAT II Shears With Ultrasonic Mode, 5mm, 25cm (TB2-0525FC); THUNDERBEAT II Shears With Ultrasonic Mode, 5mm, 20cm (TB2-0520FC) |
Olympus Medical Systems Corporation |
10/07/2025 | GEI |
| K252572 | Prodeon Urethral Sheath System | Prodeon Medical, Inc. | 10/07/2025 | FED |
| K250364 | Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV Toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV Multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens |
St. shine Optical Co., Ltd. |
10/07/2025 | LPL |
| K252948 | TrueBeam, TrueBeam STX, Edge And VitalBeam |
Varian Medical Systems, Inc. |
10/07/2025 | IYE |
| K244041 | Ultrasound Therapy Workstation (XMS-UET2) |
Xemis Medical Technology (Shenzhen) Co., Ltd. |
10/07/2025 | IMG |
| K252140 | Heylo™ System | Coloplast Corp | 10/06/2025 | EXB |
| K250173 | Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube With TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube With TaperGuard™ Cuff, Murphy Eye (119-XXNR) |
Covidien LLC | 10/06/2025 | BTR |
| K252007 | BlineSlide | Deep Breathe Inc. | 10/06/2025 | QIH |
| K252502 | Folding Mobility Scooter (KD101) |
Nanjing Kangni Smart Technology Co.,Ltd. |
10/06/2025 | INI |
| K251603 | Tigertriever 17 Ultra Revascularization Device |
Rapid Medical Ltd. | 10/06/2025 | NRY |
| K251565 | Wheelchair (N817) | ZHEJIANG TOPWE TOOLS MANUFACTURING CO.,LTD |
10/06/2025 | ITI |
| K250073 | Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 |
Tosoh Bioscience, Inc. | 10/03/2025 | PDJ |
| K250031 | Amplatzer Guidewire | Abbott Medical | 10/03/2025 | DQX |
| K251646 | Extricare® 1000 Negative Pressure Wound Therapy System |
Alleva Medical Devices | 10/03/2025 | OMP |
| K251639 | Xvision Spine System | Augmedics Ltd. | 10/03/2025 | SBF |
| K250662 | Bunkerhill MAC | BunkerHill Health | 10/03/2025 | JAK |
| K250028 | Anti Snore Mouthpiece | Dongguan Yiyao Science & Technology Development Co., Ltd. |
10/03/2025 | LRK |
| K250039 | HPACS | HealthHub | 10/03/2025 | LLZ |
| K251468 | Sleeved IC 3 Family Sleeved IC 3 SWT (name Not Finalized) Sleeved IC 3 Pocket (name Not Finalized) Sleeved IC 3 Plus (name Not Finalized) Sleeved IC 3 Plus Pocket (name Not Finalized) (N/A) |
Hollister Incorporated | 10/03/2025 | EZD |
| K252820 | PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus) |
Internacional Farmacéutica S.A de C.V |
10/03/2025 | GAM |
| K251426 | Da Vinci SP Surgical System (SP1098) |
Intuitive Surgical, Inc. | 10/03/2025 | NAY |
| K251464 | TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser Unit) |
Jeisys Medical Incorporated |
10/03/2025 | GEX |
| K252178 | MAGENTIQ-COLO (ME-APDS) | Magentiq Eye LTD | 10/03/2025 | QNP |
| K252517 | Manual Wheelchair (SYIV100A008) |
Ningbo Shenyu Medical Equipment Co.,Ltd |
10/03/2025 | IOR |
| K251859 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) |
Olympus Medical Systems Corporation |
10/03/2025 | ODG |
| K243968 | Revolve Surgical System | Revolve Surgical Inc. | 10/03/2025 | GCJ |
| K242946 | HESTIA (L200-A) | Senbitec Co., Ltd | 10/03/2025 | GEX |
| K252806 | Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.) |
Shanghai AnQing Medical Instrument Co., Ltd. |
10/03/2025 | FGB |
| K252129 | AETOS Shoulder System Stemless Humeral Prosthesis |
Smith & Nephew, Inc. | 10/03/2025 | PKC |
| K252114 | MTS Aztreonam-Avibactam 0.016/4 - 256/4 Μg/ml |
Liofilchem s. r. l. | 10/02/2025 | JWY |
| K243152 | GelPOINT V-Path Transvaginal Access Platform With Retroperitoneal Access Device |
Applied Medical Resources Corp. |
10/02/2025 | HEW |
| K252059 | CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve And Conduit (SGPV00) |
Artivion, Inc. | 10/02/2025 | OHA |
| K250860 | BreatheBand® (Model 1000) | Exemplar Medical, LLC | 10/02/2025 | BYI |
| K251124 | G-Bond Universal | GC America, Inc. | 10/02/2025 | KLE |
| K252440 | EasyTeleMed (2.0.2) | Ingeniars S.r.l. | 10/02/2025 | DRG |
| K251442 | TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) |
Ningbo Tianyi Medical Appliance Co., Ltd. |
10/02/2025 | FJK |
| K252758 | Cannulated Screw And Kirschner (K Wire) System |
OrthoNovis, Inc. | 10/02/2025 | HWC |
| K251215 | Philips IntelliSpace Cardiovascular |
Philips Medical Systems Nederland B.V. |
10/02/2025 | LLZ |
| K251398 | IPL Hair Removal Device (IPL-001, IPL-002) |
Shenzhen Enmind Technology Co., Ltd. |
10/02/2025 | OHT |
| K252769 | Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116) |
Shenzhen Finicare Co., Ltd. |
10/02/2025 | DXN |
| K250551 | 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) |
Shenzhen Sophway Technology Co., Ltd. |
10/02/2025 | GCJ |
| K250523 | Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5) |
Simergent, LLC | 10/02/2025 | FKX |
| K250766 | LungQ 4 | Thirona BV | 10/02/2025 | JAK |
| K251501 | Visby Medical Men's Sexual Health Test |
Visby Medical, Inc. | 10/01/2025 | QEP |
| K252447 | Picosecond Laser Device (BMPS4) |
Hebei Newangie Technology Co., Ltd. |
10/01/2025 | GEX |
| K252096 | Light Therapy Decollete Mask (1019135) |
Merchsource LLC | 10/01/2025 | OHS |
| K251899 | E Blator | New Deantronics Taiwan Ltd. |
10/01/2025 | GEI |
| K250767 | Newclip Patient-matched Instrumentation Non Sterile PSI |
NewClip Technics | 10/01/2025 | PBF |
| K250083 | PRO-DOSE System | Nu-Rise, SA | 10/01/2025 | NZT |
| K252804 | Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S BS, UI20S DB, UI20S GP, UI20S GR, UI20S MP, UI20S PW, UI20S RE, UI20S WH, UI20WG;UI20 BK, UI20 BL, UI20 BR, UI20 BS, UI20 DB, UI20 GP, UI20 GR, UI20 MP, UI20 PN, UI20 PW, UI20 RE, UI20 WH; UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB,UI06 PR, UI06 OG,UI06RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG; UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU; UI04 MK, UI04 BN, UI04 BU, UI04 CB, UI04 GY, UI04 LG, UI04 DG, UI04 PL, |
Shenzhen Ulike Smart Electronics Co., Ltd. |
10/01/2025 | OHT |
| K251825 | Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG) |
Shenzhen Ulike Smart Electronics Co.,Ltd. |
10/01/2025 | OHS |
| K251767 | Vena MicroAngioscope™ System | Vena Medical Holdings Corp |
10/01/2025 | LYK |
| K250026 | Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/F H3000/FH1000) |
Wuxi Hisky Medical Technologies Co., Ltd. |
10/01/2025 | IYN |
| K252072 | Francisella Tularensis Real-time PCR Assay |
Centers for Disease Control and Prevention |
09/30/2025 | SGA |
| K250050 | Midiagnostics HSV-1&2 CSF Test | miDiagnostics nv | 09/30/2025 | PGH |
| K251690 | Arthrex SpeedFLEX™ Implant | Arthrex Inc. | 09/30/2025 | OWY |
| K250331 | Astrasono A3Pro Bladder Scanner (A3Pro) |
Astrasono Technology Co., Ltd |
09/30/2025 | IYO |
| K251197 | Dexter L6 System | Distalmotion, SA | 09/30/2025 | SDD |
| K252722 | Biopsy Forceps | FEHLING Instruments GmbH | 09/30/2025 | DWZ |
| K251799 | Mobility Scooter (BBR-Q40-01); Mobility Scooter (BBR-Q40-02); Mobility Scooter (BBR-Q40-03); Mobility Scooter (BBR-Q40-04); Mobility Scooter (BBR-Q40-05); Mobility Scooter (BBR-Q40-06) |
Jiangsu Bangbang Intelligent Technology Co., Ltd. |
09/30/2025 | INI |
| K252106 | External Fixation Mini Rail System |
Paragon 28, Inc. | 09/30/2025 | KTT |
| K251669 | IBP Transducer Adapter Cable, Argon/BD/Ohmeda, 2m; IBP Transducer Adapter Cable, Draeger 10-pin, 2m; IBP Transducer Adapter Cable, Draeger 7-pin, 2m; IBP Transd. Adapter Cbl, Abbott/Medex, Smiths/TranStar 2m; IBP Transducer Adapter Cable, Baxter/Edwards, 0.3m; IBP Transducer Adapter Cable, Baxter/Edwards, 2m; IBP Transducer Adapter Cable, Argon/BD/Ohmeda, 0.3m; IBP Transducer Adapter Cable, Draeger 10-pin, 0.3m; IBP Transducer Adapter Cable, Draeger 7-pin, 0.3m; IBP Transducer Adapter |
Shanghai Draeger Medical Instrument Co., Ltd. |
09/30/2025 | DSA |
| K243270 | TigerConnect Alarm Management | TigerConnect | 09/30/2025 | MSX |
| K252085 | Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom) |
Wright Medical Technology, Inc. (Stryker Corporation) |
09/30/2025 | MQV |
| K252770 | Ilet ACE Pump | Beta Bionics, Inc. | 09/29/2025 | QFG |
| K250023 | SMART PCFD | Disior Ltd | 09/29/2025 | QIH |
| K253236 | G-BLOCK | Graphenano Dental S.L. | 09/29/2025 | EBF |
| K250123 | Master-Pin X (MP Pin With Thread) (36BMP000030 / MP30) |
Hager & Meisinger GmbH | 09/29/2025 | DZL |
| K251334 | NEW DOUBLO 2.0 | Hironic Co., Ltd. | 09/29/2025 | GEI |
| K243833 | Portable Oxygen Concentrator (JAY-1000P) |
LONGFIAN SCITECH CO., LTD |
09/29/2025 | CAW |
| K243983 | Paltop Dental Implant System | Paltop Advanced Dental Solutions, Ltd |
09/29/2025 | DZE |
| K252594 | UltraGuideCTR® Image Guided Soft Tissue Release System |
Sonex Health | 09/29/2025 | HRX |
| K252441 | Primero Safe Access System | South53, LLC. | 09/29/2025 | DYB |
| K252054 | SpineAR SNAP (SyncAR Spine) | Surgical Theater, Inc. | 09/29/2025 | SBF |
| K252051 | Allay Nerve Cap (TL5515-1); Allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627) |
Tulavi Therapeutics, Inc. |
09/29/2025 | SBG |
| K251104 | SureTome™ SW Sphincterotome With DomeTip |
Wilson-Cook Medical | 09/29/2025 | KNS |
| K250659 | LoFric Origo | Wellspect AB | 09/26/2025 | EZD |
| K251208 | Tuned Self-Fitting Mobile App | Tuned Ltd. | 09/26/2025 | SCR |
| K252221 | Inset Reverse Total Shoulder System |
Shoulder Innovations, Inc. |
09/26/2025 | |
| K251262 | S.I.N. Dental Implant System | S.I.N. Implant System Ltda |
09/26/2025 | DZE |
| K250318 | Planmed XFI | Planmed Oy | 09/26/2025 | SFV |
| K251986 | AUXILIARY WATER TUBE MAJ-855 | Olympus Medical Systems Corporation |
09/26/2025 | OCX |
| K251919 | Thulium Laser System (Deluxlase) |
Nanjing Bestview Laser S&T Co., Ltd. |
09/26/2025 | GEX |
| K250093 | Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) |
Linshom Medical, Inc. | 09/26/2025 | BZQ |
| K252105 | Ligence Heart | Ligence, UAB | 09/26/2025 | QIH |
| K252435 | Magnetic Surgical System | Levita Magnetics International Corp |
09/26/2025 | PNL |
| K251204 | FUJIFILM Stiffening Wire Device (SW-2000) |
FUJIFILM Healthcare Americas Corporation |
09/26/2025 | FDA |
| K251275 | VitalStream ART Connect; VitalStream-Hemo |
Caretaker Medical | 09/26/2025 | DXG |
| K251645 | Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 With Calculated DAP |
Canon Medical Systems Corporation |
09/26/2025 | JAK |
| K252921 | Radial Jaw 4 Pulmonary Biopsy Forceps |
Boston Scientific Corporation |
09/26/2025 | BWH |
| K252700 | Optima Coil System (Optima Packing Coil System) |
Balt USA, LLC | 09/26/2025 | HCG |
| K252102 | Alinity M HCV | Abbott Molecular Inc. | 09/25/2025 | MZP |
| K251868 | Panther Fusion GI Bacterial Assay |
Hologic | 09/25/2025 | PCH |
| K251993 | Panther Fusion GI Expanded Bacterial Assay |
Hologic Inc. | 09/25/2025 | PCH |
| K252062 | The Sensititre 18-24 Hour MIC Or Breakpoint Susceptibility System With Colistin In The Dilution Range Of 0.12-16 Ug/ml |
Thermofisher Scientific | 09/25/2025 | JWY |
| K244009 | Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens For Daily Wear (Daily Wear); Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens (Daily Disposable) |
Yung Sheng Optical Co., Ltd. |
09/25/2025 | LPL |
| K252063 | Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN) |
Wuhan Dimed Laser Technology Co., Ltd. |
09/25/2025 | GEX |
| K252725 | Stem Extension Line (U2 Total Knee System—PSA Type) |
United Orthopedic Corporation |
09/25/2025 | JWH |
| K251971 | RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer |
Stryker Instruments | 09/25/2025 | OLO |
| K252371 | Umr 680 | Shanghai United Imaging Healthcare Co., Ltd. |
09/25/2025 | LNH |
| K250837 | Pulse Oximeter | Shanghai Berry Electronic Tech Co., Ltd |
09/25/2025 | DQA |
| K251527 | Brain WMH | Quantib BV | 09/25/2025 | QIH |
| K251997 | Single-Use Biopsy Valve (MAJ-1555) |
Olympus Medical Systems Corporation |
09/25/2025 | OCX |
| K251789 | EMBOTRAP III Revascularization Device |
Neuravi Limited | 09/25/2025 | NRY |
| K251812 | Steripath® Flow™ Blood Collection System |
Magnolia Medical Technologies |
09/25/2025 | JKA |
| K251148 | JDEvolution Plus L And JDEvolution Plus LE |
JDentalCare Srl | 09/25/2025 | |
| K250076 | Endeavor™ Stand-Alone Cervical IBF System |
Innovasis | 09/25/2025 | OVE |
| K251465 | Root Canal Repair Materials (nRoot BP) |
Enpuno Biotechnology Co., Ltd |
09/25/2025 | KIF |
| K243785 | Shiley™ Oral/Nasal Tracheal Tube With TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced With Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless Reinforced |
Covidien LLC | 09/25/2025 | BTR |
| K251512 | Hi Bebe Super (BT-150B) | Bistos Co., Ltd. | 09/25/2025 | HGX |
| K251791 | Auxano® Wedge Fixation System | Auxano Medical LLC | 09/25/2025 | PLF |
| K252013 | EnSite™ X EP System | Abbott Medical | 09/25/2025 | DQK |
| K250792 | T:slim X2 Insulin Pump With Interoperable Technology |
Tandem Diabetes Care, Inc. |
09/24/2025 | QFG |
| K252227 | Pounce(TM) Sheath | Surmodics, Inc. | 09/24/2025 | DYB |
| K252680 | Celerity™ 20 HP Biological Indicator |
STERIS Corporation | 09/24/2025 | FRC |
| K250045 | Uws-angio Pro | Shanghai United Imaging Healthcare Co., Ltd. |
09/24/2025 | LLZ |
| K252183 | Resitu Slider 09 (RESL09) | Resitu Medical AB | 09/24/2025 | KNW |
| K251734 | ProVee Video Processing Unit (PV-003) |
ProVerum Limited | 09/24/2025 | FET |
| K243910 | Retraxil | Kulzer, LLC | 09/24/2025 | MVL |
| K252689 | MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) |
Imaxeon Pty Ltd | 09/24/2025 | IZQ |
| K244029 | ROBOPERA (ER-R-002); ROBOPERA (ER-R-003) |
EndoRobotics Co., Ltd. | 09/24/2025 | FDF |
| K251206 | Digital X-Ray DentiMax Pro Imaging System |
DENTIMAX, INC | 09/24/2025 | MUH |
| K252703 | LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard With Pressure Monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse With Pressure Monitoring (M0067940500) |
Boston Scientific Corporation |
09/24/2025 | FGB |
| K250071 | Alma FemiLift Pixel CO2 Laser System, Delivery Devices And Accessories |
Alma Lasers, Inc | 09/24/2025 | GEX |
| K252682 | LenSx Laser System (8065000944) |
Alcon Laboratories, Inc. | 09/24/2025 | OOE |
| K251140 | Zenflow Spring Scope | Zenflow, Inc. | 09/23/2025 | FAJ |
| K252043 | Bipolar Applicator CelonProBreath (WB990310); Bipolar Applicator CelonProSleep Plus (WB990311); Bipolar Applicator CelonProBreath (WB990210); Bipolar Applicator CelonProSleep Plus (WB990211) |
Olympus Winter & Ibe GmbH |
09/23/2025 | GEI |
| K252644 | PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION™ PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture |
M/s. Meril Endo Surgery Private Limited |
09/23/2025 | NEW |
| K251973 | Luminance Red Cold Sore Device (TN1927G) |
Luminance Medical Ventures, Inc. |
09/23/2025 | OKJ |
| K251987 | Rapid Aortic Measurements | iSchemaView, Inc. | 09/23/2025 | QIH |
| K252045 | Ion Endoluminal System (IF1000) |
Intuitive Surgical, Inc. | 09/23/2025 | EOQ |
| K251894 | Himaging Bronchscope System | Himaging Technology (Shanghai) Co., Ltd. |
09/23/2025 | EOQ |
| K253053 | Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21- B1) |
Hangzhou SHINING3D Dental Technology Co., Ltd. |
09/23/2025 | EBF |
| K251982 | Edwards MC3 Tricuspid Annuloplasty Ring (4900) |
Edwards Lifesciences LLC | 09/23/2025 | KRH |
| K250209 | Polyvinyl Alcohol Embolic Microspheres |
Canyon Medical Inc. | 09/23/2025 | KRD |
| K251483 | SwiftSight-Brain | AIRS Medical Inc. | 09/23/2025 | QIH |
| K250205 | Babio® Virus Transport Kit (Non-inactivating) |
Jinan Babio Biotechnology Co., Ltd. |
09/22/2025 | JSM |
| K251743 | SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System |
Surgical Principals, Inc. |
09/22/2025 | GCJ |
| K250388 | ENDOFLATOR + | Karl Storz SE & Co. KG | 09/22/2025 | HIF |
| K243645 | IC-Flow™ Imaging System 2.0 | Diagnostic Green GMBH | 09/22/2025 | IZI |
| K252315 | Santreva™-ATK Endovascular Revasculariztion Catheter |
AngioSafe, Inc. | 09/22/2025 | PDU |
| K241868 | Xr IVD | Tempus AI, Inc. | 09/19/2025 | PZM |
| K250408 | Alegria Flash ENA Screen | ZEUS Scientific | 09/19/2025 | LLL |
| K251002 | Videa Dental AI | VideaHealth Inc. | 09/19/2025 | MYN |
| K252285 | Well-Root PT | Vericom Co., Ltd. | 09/19/2025 | KIF |
| K252613 | Unscented Menstrual Three-piece Applicator Tampon |
Unibeauty (Hubei) Technology Co.,Ltd. |
09/19/2025 | HEB |
| K244035 | Portable Mesh Nebulizer (JM821) |
Shenzhen Jermei Medical Device Technology Co., Ltd. |
09/19/2025 | CAF |
| K251167 | Udr Aurora CX | Shanghai United Imaging Healthcare Co., Ltd. |
09/19/2025 | KPR |
| K243990 | BondEase 2 Topical Skin Adhesive |
OptMed, Inc. | 09/19/2025 | MPN |
| K251867 | EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V) |
Olympus Medical Systems Corp. |
09/19/2025 | FDT |
| K252657 | Impact PEEK Union Nail System | Nvision Biomedical Technologies INC. |
09/19/2025 | HTY |
| K252662 | UniBur | Nakanishi Inc. | 09/19/2025 | HBE |
| K251689 | VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11) |
NAKANISHI INC. | 09/19/2025 | ELC |
| K243920 | Purema H Hemoconcentrator - Pediatric |
MEDICA USA Inc. | 09/19/2025 | KDI |
| K250450 | Coated Hip Implants | Medacta International S.A. |
09/19/2025 | LZO |
| K251100 | IPGTFL-02 | IPG Medical Corporation | 09/19/2025 | GEX |
| K242859 | VEGA | Ibramed Equipamentos Médicos |
09/19/2025 | GEX |
| K250777 | Sonicaid Team3 | Huntleigh Healthcare Ltd. |
09/19/2025 | HGM |
| K250953 | EQUIA LC ONE | GC America Inc. | 09/19/2025 | EMA |
| K252647 | Tapestry Biointegrative Implant |
Embody, Inc. | 09/19/2025 | OWY |
| K250649 | Bunkerhill ECG-EF | BunkerHill Health | 09/19/2025 | QYE |
| K250128 | Single Use Suction-Evacuation Ureteral Access Sheath |
ANHUI HAPPINESS WORKSHOP MEDICAL INSTRUMENTS CO., LTD |
09/19/2025 | FED |
| K252428 | Electric Wheelchair (Model P2) | Superpi Robot Co., Ltd. | 09/18/2025 | ITI |
| K251649 | Sunny Plus (Sunny) | ShenB Co., Ltd | 09/18/2025 | NFO |
| K251597 | InnerView System | Perimetrics, Inc. | 09/18/2025 | EKX |
| K250883 | ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R) |
Olympus Medical Systems Corporation |
09/18/2025 | ITX |
| K251905 | Normatec Elite Hip | NormaTec Industries, LP | 09/18/2025 | IRP |
| K251479 | Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage (PLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Transforaminal Lumbar Interbody Fusion Cage (TLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Direct Lateral Lumbar Interbody Fusion Cage (DLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Anterior Lumbar Interbody Fusion Cage (ALIF)) |
Mobarn Medical Devices, LLC. |
09/18/2025 | MAX |
| K251377 | Magic InBra | Medela AG | 09/18/2025 | HGX |
| K250369 | Axial3D Insight | Axial Medical Printing Limited |
09/18/2025 | QIH |
| K251902 | Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask With Shield (Vitaform-FS) |
Vitacore Industries Inc. | 09/17/2025 | FXX |
| K243752 | Double Tube Herbst Appliance | the tmj clinic PC | 09/17/2025 | LRK |
| K251623 | Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061 ) |
Shenzhen Yicai Health Technology Co. Ltd |
09/17/2025 | IRP |
| K252615 | Ruthless Spine RJB | Ruthless, LLC dba Ruthless Spine |
09/17/2025 | QWL |
| K251446 | PlasmaFlow X Compression Sleeve Device (XPF0001) |
ManaMed, LLC | 09/17/2025 | JOW |
| K252035 | DENTURE SOFT EX (Pink Set); DENTURE SOFT EX (White Set); DENTURE SOFT EX (Pink Powder); DENTURE SPFT EX (White Powder); DENTURE SOFT EX (Liquid); DENTURE SOFT EX (Trial Kit Pink); DENTURE SOFT EX (Trial Kit White) |
Kamemizu Chemical Industry Co., Ltd |
09/17/2025 | EBI |
| K244006 | FG Bone Graft M | Full Golden Biotech Co., Ltd. |
09/17/2025 | LYC |
| K251386 | ECHELON Synergy | Fujifilm Corporation | 09/17/2025 | LNH |
| K251688 | Carpentier-Edwards Physio Annuloplasty Ring (4450) |
Edwards Lifesciences LLC | 09/17/2025 | KRH |
| K251221 | Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) |
Abbott | 09/17/2025 | MXD |
| K251095 | Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses |
Pegavision Corporation | 09/17/2025 | LPL |
| K251676 | Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S) |
Microtek Medical LLC | 09/16/2025 | LHI |
| K252540 | ACCUJECT Injector Set 2.1-1P (LP604590) |
Medicel AG | 09/16/2025 | MSS |
| K251650 | Insight Enhanced™ DRF (EN-1002-01) |
Imaging Engineering LLC | 09/16/2025 | JAA |
| K242287 | SFIT Abutment | Cowellmedi Co., Ltd. | 09/16/2025 | NHA |
| K250609 | Sober Self-Test | Sober IP LLC | 09/15/2025 | DIC |
| K252128 | Zener® (model ZEN-001-B1) | UVX Inc. | 09/15/2025 | FRA |
| K251780 | Igps Navigation Instruments | SI-BONE Inc. | 09/15/2025 | OLO |
| K252598 | Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) |
Shanghai AnQing Medical Instrument Co., Ltd. |
09/15/2025 | FAJ |
| K251869 | Disposable Prophy Angle (3399-60, 3399-090, 3399-105) |
Premium Plus (Dongguan) Limited |
09/15/2025 | EGS |
| K251914 | IPL Hair Removal Device (MLY-M011); IPL Hair Removal Device (MLY-M012); IPL Hair Removal Device (MLY-M013); IPL Hair Removal Device (MLY-M015); IPL Hair Removal Device (MLY-T001); IPL Hair Removal Device (MLY-T002) |
Miley Technology (Hebei) Co., Ltd. |
09/15/2025 | OHT |
| K252443 | SpaceFix Shoulder Spacer | G21 S.R.L | 09/15/2025 | MBB |
| K250237 | InferOperate Suite | Beijing Infervision Healthcare Medical Technology Co., Ltd. |
09/15/2025 | QIH |
| K250689 | CloudTMS Edge | TeleEMG, LLC | 09/14/2025 | OBP |
| K251449 | BrainsWay Deep TMS System | BrainsWay Ltd. | 09/13/2025 | OBP |
| K251518 | Volta AF-Xplorer II | Volta Medical | 09/12/2025 | DQK |
| K252554 | Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup |
VivaChek Biotech (Hangzhou) Co., Ltd |
09/12/2025 | NFT |
| K251170 | Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter And Tangent Digital Controller |
Tangent Endoscopy LLC | 09/12/2025 | FBN |
| K252595 | Stethophone Pro | Sparrow Acoustics Inc. | 09/12/2025 | DQD |
| K251820 | ViewMateTM Ultrasound System | Shenzhen Mindray Bio-medical Electronics Co., Ltd. |
09/12/2025 | IYN |
| K250040 | Uws-angio | Shanghai United Imaging Healthcare Co., Ltd. |
09/12/2025 | LLZ |
| K252576 | Legend X Platform | Pollogen Ltd | 09/12/2025 | GEI |
| K252586 | CADDIE | Odin Medical Limited | 09/12/2025 | QNP |
| K250047 | Bite Away Two | MibeTec, GmbH | 09/12/2025 | IRT |
| K250986 | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) |
Mevion Medical Systems, Inc. |
09/12/2025 | LHN |
| K250628 | DynaNail TTC Fusion System | MedShape, Inc. | 09/12/2025 | HSB |
| K252225 | PowerKnot High Strength Sutures |
Medacta International S.A. |
09/12/2025 | GAT |
| K252027 | Vertex(TM) Catheter | Jupiter Endovascular | 09/12/2025 | DYB |
| K250445 | Fast Warm - NX | FUJIFILM Irvine Scientific |
09/12/2025 | MQL |
| K251843 | Erchonia EVRL | Erchonia Corporation | 09/12/2025 | OLP |
| K251083 | Compact II | Enraf-Nonius, B.V. | 09/12/2025 | IPF |
| K252189 | LED Light Therapy Mask (2311, 2344, 2457, 2458) |
Dongguan Yanxi Technology Co., Ltd. |
09/12/2025 | OHS |
| K251368 | FETOLY | Diagnoly | 09/12/2025 | IYN |
| K252562 | Spine & Trauma Navigation Instruments |
Brainlab AG | 09/12/2025 | OLO |
| K252593 | LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312) |
Boston Scientific Corporation |
09/12/2025 | MXD |
| K243864 | BONX805 | BONTECH Co., Ltd. | 09/12/2025 | IZL |
| K250059 | BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O) |
Becton, Dickinson and Company |
09/12/2025 | ONB |
| K250507 | Hypertension Notification Feature (HTNF) |
Apple Inc. | 09/11/2025 | SFR |
| K250797 | UV5000 Handle | UroViu Corporation | 09/11/2025 | FAJ |
| K251758 | Serafin® | TNS Co., Ltd. | 09/11/2025 | NXC |
| K251826 | RENASYS WOUND+ Dressing Kit With AIRLOCK Technology |
Smith & Nephew Medical Ltd |
09/11/2025 | OMP |
| K251316 | Mazor X System / Mazor X Stealth Edition |
Mazor Robotics Ltd. | 09/11/2025 | OLO |
| K252520 | SEFRIA™ Hydrocodone Oral Fluid |
Immunalysis Corporation | 09/11/2025 | DJG |
| K251399 | SIGNA™ Sprint | GE Medical Systems, LLC | 09/11/2025 | LNH |
| K243926 | Vivatmo Pro-s | Bosch Healthcare Solutions GmbH |
09/11/2025 | MXA |
| K251158 | PowerWire® 14 Radiofrequency Guidewire Kit |
Baylis Medical Technologies Inc. |
09/11/2025 | PDU |
| K242314 | Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2) |
Augment Intelligent Medical System (China) Co., Ltd. |
09/11/2025 | LLZ |
| K251320 | XTRA4 | AL.CHI.MI.A. S.r.l | 09/11/2025 | LYX |
| K252374 | Nylon Flextap(r) | Airway Technologies d/b/a Airway Management |
09/11/2025 | LRK |
| K250216 | OsteoProbe (OP-100) | Active Life Scientific, Inc. |
09/11/2025 | QGQ |
| K251573 | VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens |
VIZIONFOCUS INC. | 09/10/2025 | LPL |
| K250464 | Enlight 2100 (TPL-E2103-0) | Timpel S.A. | 09/10/2025 | |
| K250734 | OptiLUV Device | Pollogen Ltd. | 09/10/2025 | PBX |
| K252527 | Surfacer Inside-Out Access Catheter System |
Merit Medical System Inc. |
09/10/2025 | QJH |
| K251817 | Da Vinci SP Surgical System (SP1098) |
Intuitive Surgical Inc. | 09/10/2025 | NAY |
| 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 |
| K252580 | Iq200 Series | Beckman Coulter, Inc | 09/10/2025 | LKM |
| K244002 | AngioWaveNet | Angiowave Imaging, Inc. | 09/10/2025 | QIH |
| K252530 | OptiVu™ Shoulder | MR Surgical Solutions, LLC |
09/10/2025 | SBF |
| K250483 | PhotonBlade 3; PhotonBlade 3 Smoke Evacuation |
Stryker Instruments | 09/09/2025 | GEI |
| K251682 | MuscleView 2.0 | Springbok, Inc. (dba Springbok Analytics) |
09/09/2025 | LNH |
| K252608 | AI-Rad Companion Prostate MR | Siemens Healthcare GmbH | 09/09/2025 | LLZ |
| 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 |
| K251891 | Electric Wheelchair (GY-E001) | Shandong Guyue Healthcare Appliance Co., Ltd. |
09/09/2025 | ITI |
| K252477 | Hybrid Viewer (00859873006240) | Hermes Medical Solutions AB |
09/09/2025 | KPS |
| K251040 | MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test |
Guangzhou Decheng Biotechnology Co., Ltd. |
09/09/2025 | LCX |
| 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 |
| K252181 | AquaA | Fresenius Medical Care North America |
09/09/2025 | FIP |
| K252524 | Quadsense (Quadsense And Quadsense Pro) |
Eventum Orthopaedics Ltd | 09/09/2025 | ONN |
| K251072 | Segmentron Viewer | DGNCT, LLC | 09/09/2025 | QIH |
| K250922 | Edema Guard Monitor (EGM) CardioSet-001 |
CardioSet Medical Ltd. | 09/09/2025 | DSB |
| K243846 | Access Anti-hav | Beckman Coulter Inc. | 09/09/2025 | LOL |
| K251957 | Coaptium Connect With Tissium Light |
TISSIUM SA | 09/08/2025 | SFD |
| K251931 | BioTraceIO Vision (V1.7) | Techsomed Medical Technologies |
09/08/2025 | QTZ |
| K251754 | Wearable Breast Pump (Model S33) |
Shenzhen TPH Technology Co., Ltd. |
09/08/2025 | HGX |
| K251394 | Momcozy Wearable Breast Pump (BP223) |
Shenzhen Root Innovation Technology Co., Ltd. |
09/08/2025 | HGX |
| K250960 | DUO Microcatheter | REV Neuro LLC | 09/08/2025 | QJP |
| K251610 | Qer-cta (v1.0) | Qure.ai Technologies | 09/08/2025 | QAS |
| K250928 | OmniTom Elite With PCD | NeuroLogica Corporation | 09/08/2025 | JAK |
| K250229 | Dual Action Tissue Closure Device |
Micro-Tech (Nanjing) Co., Ltd |
09/08/2025 | PKL |
| K251892 | MAXXOS P.A.C.E. Foot & Ankle Plating System |
MAXXOS Medical GmbH | 09/08/2025 | HRS |
| K251227 | Da Vinci Surgical System (IS5000) |
Intuitive Surgical, Inc. | 09/08/2025 | NAY |
| K250132 | Ureteral Access Sheath | Zhejiang YiGao Medical Technology Co., Ltd. |
09/05/2025 | FED |
| 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 |
| K250095 | All-Suture Dual Anchor System | SutureTech, Inc. | 09/05/2025 | MBI |
| 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 |
| K243795 | Preboa-pro Catheter | Prytime Medical Devices, Inc. |
09/05/2025 | MJN |
| K250460 | WatchPAT400 (WP400) | Itamar Medical Ltd. | 09/05/2025 | MNR |
| K252528 | Ion Endoluminal System (IF1000) |
Intuitive Surgical Inc. | 09/05/2025 | EOQ |
| K251317 | SOLOPASS 2.0 System | inTRAvent Medical Partners |
09/05/2025 | HAW |
| K251753 | GenaCheck COVID-19 Rapid Self-Test |
Genabio Diagnostics Inc | 09/05/2025 | QYT |
| 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 |
| K251022 | 3D-SHAPER | 3D-SHAPER MEDICAL S.L | 09/05/2025 | KGI |
| K244038 | High Pressure Tubing | Shandong INT Medical Instruments Co., Ltd. |
09/05/2025 | DXT |
| K251733 | Fluido® AirGuard System | The Surgical Company International BV (as TSC Life) |
09/04/2025 | LGZ |
| K251781 | KALA MINI 2.0 (KALA-04) | Shenzhen Kaiyan Medical Equipment Co., Ltd. |
09/04/2025 | OHS |
| K250770 | Optina-4C (MHRC-C1N) | Optina Diagnostics Inc. | 09/04/2025 | HKI |
| K250353 | Oniris; Oniris Plus | Oniris | 09/04/2025 | LRK |
| K250064 | Dose+ (1.0) | Mvision AI Oy | 09/04/2025 | MUJ |
| K243789 | LIBERTY Endovascular Robotic System (LIBERTYOS) |
Microbot Medical Ltd. | 09/04/2025 | DXX |
| K251545 | Intense Pulsed Light Therapy Device (MMABM-1) |
Micowey Medical Equipment (Guangxi) Co., LTD |
09/04/2025 | ONF |
| K251444 | Endoskeleton™ Interbody Systems |
Medtronic Sofamor Danek USA, Inc. |
09/04/2025 | MAX |
| K251510 | Symani Surgical System | Medical Microinstruments, Inc. |
09/04/2025 | SAQ |
| K251737 | NextAR(TM) Shoulder Platform | Medacta International S.A. |
09/04/2025 | SBF |
| K243700 | Apollo TMS Therapy System | MAG & More GmbH | 09/04/2025 | OBP |
| K251533 | Rapid Obstructive Hydrocephalus, Rapid OH |
iSchemaView Inc. | 09/04/2025 | QAS |
| K251438 | Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) |
Guilin Woodpecker Medical Instrument Co., Ltd. |
09/04/2025 | EHD |
| 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 |
| K251656 | Careverse CoronaryDoc (Careverse CoronaryDoc) |
Careverse Technology Pte. Ltd. |
09/04/2025 | QIH |
| K251168 | Image Suite | Carestream Health Inc. | 09/04/2025 | LLZ |
| K250893 | Ball Joint Guide Array (66295) | Bayer Medical Care, Inc. | 09/04/2025 | HAW |
| 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 |
| K252454 | Kinos Total Ankle System | restor3d | 09/03/2025 | HSN |
| K252446 | BruxZir® NOW | Prismatik Dentalcraft, Inc. |
09/03/2025 | EIH |
| K231952 | MEDILIGHT | Medicreations LLC | 09/03/2025 | ONF |
| K251726 | SignalNED System (Model RE) | Forest Devices, Inc | 09/03/2025 | OMC |
| 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 |
| K252174 | AquaCast Mask | Blessing Cathay Corporation |
09/03/2025 | IYE |
| K251457 | Diode Laser Therapy Device (VADER) |
Beijing Superlaser Technology Co., Ltd. |
09/03/2025 | GEX |
| K250765 | AViTA Arm Type Blood Pressure Monitor Cuff |
AViTA Corporation | 09/03/2025 | DXQ |
| K252539 | Tempus Pixel | Arterys, Inc. | 09/03/2025 | QIH |
| K251575 | IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System |
Alphatec Spine | 09/03/2025 | OVD |
| K250217 | AGNES Ultra | Agnes Medical Co., Ltd | 09/03/2025 | GEI |
| K251909 | NeurotriS (SX2500); NeurotriS (SX3800) |
A-1 Engineering | 09/03/2025 | NFO |
| K250753 | VELMENI For DENTISTS (V4D) | Velmeni Inc. | 09/02/2025 | MYN |
| 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 |
| K251408 | OsteoSight™ Hip (v1) | Naitive Technologies Ltd | 09/02/2025 | SAO |
| K251975 | Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component |
Ignite OrthoMotion | 09/02/2025 | NJD |
| K242768 | Customized Abutment And Screw | Chengdu Besmile Medical Technology Co., Ltd. |
09/02/2025 | NHA |
| K251775 | RODIN Cement | Belport Company, Inc., Gingi-Pak |
09/02/2025 | EMA |
| K251615 | Aerogen Pro-X1 Controller System |
Aerogen Ltd | 09/02/2025 | SFP |
| K251718 | ArTT Augments And Buttresses And Bone Screws |
Limacorporate S.p.A. | 08/29/2025 | LPH |
| 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 |
| 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 |
| K243680 | Neurovascular Insight V1.0 | Olea Medical S.A.S. | 08/25/2025 | LLZ |
| 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 |
| 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 |
