| Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ (K251522) | Bone Solutions, Inc. | 2025-10-13 |
| COVID-19 Detect Rapid Self -Test (K251595) | InBios International, Inc. | 2025-10-12 |
| Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare Wand (HD-44) (K251034) | Shenzhen Nuon Medical Equipment Co., Ltd. | 2025-10-12 |
| GENEO X ELITE (K242227) | Pollogen, Ltd. | 2025-10-12 |
| Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (K251602) | Canon Medical Systems Corporation | 2025-10-10 |
| Zeta Navigation System (ZNS131-US) (K251927) | Zeta Surgical, Inc. | 2025-10-10 |
| Yomi Robotic System (K251835) | Neocis, Inc. | 2025-10-10 |
| Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U) (K250351) | Olympus Medical Systems Corporation | 2025-10-10 |
| HexaPLUS S OneDrill Implant System (K243078) | Osseofuse International, Inc. | 2025-10-10 |
| Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System (K250249) | Gold Standard Diagnostics, LLC | 2025-10-10 |
| Collagen Wound Dressing (K252001) | Winner Medical Co., Ltd. | 2025-10-10 |
| IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032) (K252209) | Foshan Jindi Electric Appliance Co., Ltd. | 2025-10-10 |
| Tegaderm Post-Op Transparent Antimicrobial Dressing (K251866) | Solventum US, LLC | 2025-10-10 |
| DeGen Medical Latitude-C AM Cervical Interbody Fusion System (K252737) | Degen Medical | 2025-10-10 |
| EvoEndo Single-Use Endoscopy System (K251708) | EvoEndo, Inc. | 2025-10-10 |
| Verruca-Freeze H Plus (K252903) | Cryosurgery, Inc. | 2025-10-10 |
| On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System (K250085) | ACON Laboratories, Inc. | 2025-10-10 |
| HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) (K251082) | Procept Biorobotics | 2025-10-10 |
| Eleganz IM Threaded Nail System (IM Threaded Nail System) (K252312) | Dev4 | 2025-10-10 |
| TMINI Miniature Robotic System (K252544) | THINK Surgical, Inc. | 2025-10-10 |
| SoClean 3+ (K243815) | Soclean, Inc. | 2025-10-10 |
| ORA Method LED Gua Sha (GS-04) (K252272) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-10-09 |
| SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002) (K250645) | Haemoband Surgical, Ltd. | 2025-10-09 |
| iFuse Bedrock Granite Implant System (K253094) | SI-BONE, Inc. | 2025-10-09 |
| Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753) (K251795) | Honsun (Nantong) Co., Ltd. | 2025-10-09 |
| EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A) (K251366) | Nihon Kohden Corporation | 2025-10-09 |
| DIASAFEplusUS (F00013010) (K251851) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-10-09 |
| Invisalign Specifix Attachment System (K252870) | Align Technology, Inc. | 2025-10-09 |
| COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS (K252939) | Cotton High Tech S.L. | 2025-10-09 |
| cleadew GP hydra one (K251876) | Ophtecs Corporation | 2025-10-09 |
| Orca Air/Water and Suction Valves (K252910) | Boston Scientific | 2025-10-09 |
| Pediatric Plating Platform I Small-Mini (K252600) | OrthoPediatrics Corp. | 2025-10-09 |
| EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (K251651) | Philips Ultrasound, LLC | 2025-10-09 |
| 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) (K252553) | Shenzhen Jianchao Intelligent Technology Co., Ltd. | 2025-10-09 |
| Lux HD 2530 detector (Lux HD 2530) (K252911) | Iray Imaging Technology (Haining) Limited | 2025-10-09 |
| VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup (K252867) | Advin Biotech, Inc. | 2025-10-09 |
| Elecsys Phospho-Tau (181P) Plasma (K252163) | Roche Diagnostics | 2025-10-08 |
| MetaFore Small Screw System (K250536) | Extremity Medical, LLC | 2025-10-08 |
| Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 (K252874) | Serpex Medical, Inc. | 2025-10-08 |
| GT300; GT300-C (K250060) | Genoray Co., Ltd. | 2025-10-08 |
| 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) (K250298) | Clinical Innovations, LLC | 2025-10-08 |
| CUSA® Clarity Ultrasonic Surgical Aspirator System (K251162) | Integra LifeSciences Corporation | 2025-10-08 |
| The Botticelli (Model: Athena) (K251699) | Bellamia Technologies, Inc. | 2025-10-08 |
| 14Fr Low Profile Introducer Kit (K252766) | Abiomed, Inc. | 2025-10-08 |
| ProKnow DS (K251363) | Elekta Solutions AB | 2025-10-08 |
| BD Saf-T-Intima™ Subcutaneous Catheter System (K251422) | Becton Dickinson Infusion Therapy Systems, Inc. | 2025-10-08 |
| Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) (K250187) | Olympus Medical Systems Corporation | 2025-10-07 |
| AIAS Cephalon (K252214) | Metamorphosis GmbH | 2025-10-07 |
| Eminent Spine Posterior SI System (K250894) | Eminent Spine | 2025-10-07 |
| Prodeon Urethral Sheath System (K252572) | Prodeon Medical, Inc. | 2025-10-07 |
| 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) (K252150) | Olympus Medical Systems Corporation | 2025-10-07 |
| TrueBeam, TrueBeam STX, Edge and VitalBeam (K252948) | Varian Medical Systems, Inc. | 2025-10-07 |
| Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar™ Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US) (K250688) | Acotec Scientific Co., Ltd. | 2025-10-07 |
| Ultrasound Therapy Workstation (XMS-UET2) (K244041) | Xemis Medical Technology (Shenzhen) Co., Ltd. | 2025-10-07 |
| 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 (K250364) | St. shine Optical Co., Ltd. | 2025-10-07 |
| deepLive (OSP12 + DMS) (K252851) | Damae Medical | 2025-10-07 |
| 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) (K250173) | Covidien, LLC | 2025-10-06 |
| BlineSlide (K252007) | Deep Breathe, Inc. | 2025-10-06 |
| Wheelchair (N817) (K251565) | Zhejiang Topwe Tools Manufacturing Co.,Ltd | 2025-10-06 |
| Tigertriever 17 Ultra Revascularization Device (K251603) | Rapid Medical Ltd. | 2025-10-06 |
| PainChek (PainChek Adult) (DEN240073) | Painchek Limited (Ltd.) | 2025-10-06 |
| Folding Mobility Scooter (KD101) (K252502) | Nanjing Kangni Smart Technology Co., Ltd. | 2025-10-06 |
| Heylo™ System (K252140) | Coloplast Corp. | 2025-10-06 |
| MAGENTIQ-COLO (ME-APDS) (K252178) | Magentiq Eye, Ltd. | 2025-10-03 |
| da Vinci SP Surgical System (SP1098) (K251426) | Intuitive Surgical, Inc. | 2025-10-03 |
| Manual Wheelchair (SYIV100A008) (K252517) | Ningbo Shenyu Medical Equipment Co.,Ltd | 2025-10-03 |
| HESTIA (L200-A) (K242946) | Senbitec Co., Ltd. | 2025-10-03 |
| TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit) (K251464) | Jeisys Medical Incorporated | 2025-10-03 |
| EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) (K251859) | Olympus Medical Systems Corporation | 2025-10-03 |
| Revolve Surgical System (K243968) | Revolve Surgical, Inc. | 2025-10-03 |
| HPACS (K250039) | Healthhub | 2025-10-03 |
| xvision Spine system (K251639) | Augmedics, Ltd. | 2025-10-03 |
| Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 (K250073) | Tosoh Bioscience, Inc. | 2025-10-03 |
| AETOS Shoulder System Stemless Humeral Prosthesis (K252129) | Smith & Nephew, Inc. | 2025-10-03 |
| Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.) (K252806) | Shanghai AnQing Medical Instrument Co., Ltd. | 2025-10-03 |
| Amplatzer Guidewire (K250031) | ABBOTT MEDICAL | 2025-10-03 |
| ProSense™ System (DEN220077) | Icecure Medical | 2025-10-03 |
| 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) (K251468) | Hollister Incorporated | 2025-10-03 |
| PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus) (K252820) | Internacional Farmacéutica S.A DE C.V | 2025-10-03 |
| extriCARE® 1000 Negative Pressure Wound Therapy System (K251646) | Alleva Medical Devices | 2025-10-03 |
| Anti Snore Mouthpiece (K250028) | Dongguan Yiyao Science & Technology Development Co., Ltd. | 2025-10-03 |
| Bunkerhill MAC (K250662) | BunkerHill Health | 2025-10-03 |
| MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL (K252114) | Liofilchem s.r.l. | 2025-10-02 |
| 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) (K250551) | Shenzhen Sophway Technology Co., Ltd. | 2025-10-02 |
| G-Bond Universal (K251124) | GC America, Inc. | 2025-10-02 |
| BreatheBand® (Model 1000) (K250860) | Exemplar Medical, LLC | 2025-10-02 |
| EasyTeleMed (2.0.2) (K252440) | Ingeniars S.R.L. | 2025-10-02 |
| Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116) (K252769) | Shenzhen Finicare Co., Ltd. | 2025-10-02 |
| Philips IntelliSpace Cardiovascular (K251215) | Philips Medical Systems Nederland B.V. | 2025-10-02 |
| TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) (K251442) | Ningbo Tianyi Medical Appliance Co., Ltd. | 2025-10-02 |
| LungQ 4 (K250766) | Thirona BV | 2025-10-02 |
| CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00) (K252059) | Artivion, Inc. | 2025-10-02 |
| GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device (K243152) | Applied Medical Resources Corp. | 2025-10-02 |
| Cannulated Screw and Kirschner (K wire) System (K252758) | Orthonovis, Inc. | 2025-10-02 |
| 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) (K250523) | Simergent, LLC | 2025-10-02 |
| IPL Hair Removal Device (IPL-001, IPL-002) (K251398) | Shenzhen Enmind Technology Co., Ltd. | 2025-10-02 |
| Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG) (K251825) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2025-10-01 |
| Light Therapy Decollete Mask (1019135) (K252096) | Merchsource, LLC | 2025-10-01 |
| Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000) (K250026) | Wuxi Hisky Medical Technologies Co., Ltd. | 2025-10-01 |
| E Blator (K251899) | New Deantronics Taiwan , Ltd. | 2025-10-01 |