| K252312 — Eleganz IM Threaded Nail System (IM Threaded Nail System) | Dev4 Fri Oct 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251927 — Zeta Navigation System (ZNS131-US) | Zeta Surgical, Inc. Fri Oct 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252209 — IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032) | Foshan Jindi Electric Appliance Co., Ltd. Fri Oct 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252903 — Verruca-Freeze H Plus | Cryosurgery, Inc. Fri Oct 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251708 — EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. Fri Oct 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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 Fri Oct 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252544 — TMINI Miniature Robotic System | THINK Surgical, Inc. Fri Oct 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252737 — DeGen Medical Latitude-C AM Cervical Interbody Fusion System | Degen Medical Fri Oct 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251835 — Yomi Robotic System | Neocis, Inc. Fri Oct 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243078 — HexaPLUS S OneDrill Implant System | Osseofuse International, Inc. Fri Oct 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251866 — Tegaderm Post-Op Transparent Antimicrobial Dressing | Solventum US, LLC Fri Oct 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251082 — HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) | Procept Biorobotics Fri Oct 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243815 — SoClean 3+ | Soclean, Inc. Fri Oct 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251602 — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging | Canon Medical Systems Corporation Fri Oct 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252911 — Lux HD 2530 detector (Lux HD 2530) | Iray Imaging Technology (Haining) Limited Thu Oct 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251876 — cleadew GP hydra one | Ophtecs Corporation Thu Oct 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252939 — COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS | Cotton High Tech S.L. Thu Oct 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252600 — Pediatric Plating Platform I Small-Mini | OrthoPediatrics Corp. Thu Oct 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251366 — EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A) | Nihon Kohden Corporation Thu Oct 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252272 — ORA Method LED Gua Sha (GS-04) | Shenzhen Kaiyan Medical Equipment Co., Ltd. Thu Oct 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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. Thu Oct 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252870 — Invisalign Specifix Attachment System | Align Technology, Inc. Thu Oct 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251795 — Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753) | Honsun (Nantong) Co., Ltd. Thu Oct 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251651 — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC Thu Oct 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253094 — iFuse Bedrock Granite Implant System | SI-BONE, Inc. Thu Oct 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251851 — DIASAFEplusUS (F00013010) | Fresenius Medical Care Renal Therapies Group, LLC Thu Oct 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252867 — VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup | Advin Biotech, Inc. Thu Oct 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252910 — Orca Air/Water and Suction Valves | Boston Scientific Thu Oct 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250645 — SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002) | Haemoband Surgical, Ltd. Thu Oct 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250536 — MetaFore Small Screw System | Extremity Medical, LLC Wed Oct 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252163 — Elecsys Phospho-Tau (181P) Plasma | Roche Diagnostics Wed Oct 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251363 — ProKnow DS | Elekta Solutions AB Wed Oct 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250060 — GT300; GT300-C | Genoray Co., Ltd. Wed Oct 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251699 — The Botticelli (Model: Athena) | Bellamia Technologies, Inc. Wed Oct 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251162 — CUSA® Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation Wed Oct 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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 Wed Oct 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252874 — Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 | Serpex Medical, Inc. Wed Oct 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252766 — 14Fr Low Profile Introducer Kit | Abiomed, Inc. Wed Oct 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251422 — BD Saf-T-Intima Subcutaneous Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. Wed Oct 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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 Tue Oct 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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. Tue Oct 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252572 — Prodeon Urethral Sheath System | Prodeon Medical, Inc. Tue Oct 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250894 — Eminent Spine Posterior SI System | Eminent Spine Tue Oct 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250187 — Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) | Olympus Medical Systems Corporation Tue Oct 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252214 — AIAS Cephalon | Metamorphosis GmbH Tue Oct 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252851 — deepLive (OSP12 + DMS) | Damae Medical Tue Oct 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252948 — TrueBeam, TrueBeam STX, Edge and VitalBeam | Varian Medical Systems, Inc. Tue Oct 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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. Tue Oct 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K244041 — Ultrasound Therapy Workstation (XMS-UET2) | Xemis Medical Technology (Shenzhen) Co., Ltd. Tue Oct 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252502 — Folding Mobility Scooter (KD101) | Nanjing Kangni Smart Technology Co., Ltd. Mon Oct 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |