| K251851 — DIASAFEplusUS (F00013010) | Fresenius Medical Care Renal Therapies Group, LLC Oct 9, 2025 |
| K252870 — Invisalign Specifix Attachment System | Align Technology, Inc. Oct 9, 2025 |
| K252600 — Pediatric Plating Platform I Small-Mini | OrthoPediatrics Corp. Oct 9, 2025 |
| K252911 — Lux HD 2530 detector (Lux HD 2530) | Iray Imaging Technology (Haining) Limited Oct 9, 2025 |
| K252939 — COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS | Cotton High Tech S.L. Oct 9, 2025 |
| K251366 — EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A) | Nihon Kohden Corporation Oct 9, 2025 |
| 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. Oct 9, 2025 |
| K251795 — Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753) | Honsun (Nantong) Co., Ltd. Oct 9, 2025 |
| K252272 — ORA Method LED Gua Sha (GS-04) | Shenzhen Kaiyan Medical Equipment Co., Ltd. Oct 9, 2025 |
| K251651 — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC Oct 9, 2025 |
| K253094 — iFuse Bedrock Granite Implant System | SI-BONE, Inc. Oct 9, 2025 |
| K252867 — VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup | Advin Biotech, Inc. Oct 9, 2025 |
| K252910 — Orca Air/Water and Suction Valves | Boston Scientific Oct 9, 2025 |
| K250645 — SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002) | Haemoband Surgical, Ltd. Oct 9, 2025 |
| K251162 — CUSA® Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation Oct 8, 2025 |
| K250536 — MetaFore Small Screw System | Extremity Medical, LLC Oct 8, 2025 |
| K252163 — Elecsys Phospho-Tau (181P) Plasma | Roche Diagnostics Oct 8, 2025 |
| 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 Oct 8, 2025 |
| K251699 — The Botticelli (Model: Athena) | Bellamia Technologies, Inc. Oct 8, 2025 |
| K251363 — ProKnow DS | Elekta Solutions AB Oct 8, 2025 |
| K252874 — Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 | Serpex Medical, Inc. Oct 8, 2025 |
| K250060 — GT300; GT300-C | Genoray Co., Ltd. Oct 8, 2025 |
| K252766 — 14Fr Low Profile Introducer Kit | Abiomed, Inc. Oct 8, 2025 |
| K251422 — BD Saf-T-Intima Subcutaneous Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. Oct 8, 2025 |
| 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. Oct 7, 2025 |
| 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 Oct 7, 2025 |
| K252572 — Prodeon Urethral Sheath System | Prodeon Medical, Inc. Oct 7, 2025 |
| K250894 — Eminent Spine Posterior SI System | Eminent Spine Oct 7, 2025 |
| K250187 — Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) | Olympus Medical Systems Corporation Oct 7, 2025 |
| K252214 — AIAS Cephalon | Metamorphosis GmbH Oct 7, 2025 |
| K252851 — deepLive (OSP12 + DMS) | Damae Medical Oct 7, 2025 |
| K252948 — TrueBeam, TrueBeam STX, Edge and VitalBeam | Varian Medical Systems, Inc. Oct 7, 2025 |
| 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. Oct 7, 2025 |
| K244041 — Ultrasound Therapy Workstation (XMS-UET2) | Xemis Medical Technology (Shenzhen) Co., Ltd. Oct 7, 2025 |
| K252502 — Folding Mobility Scooter (KD101) | Nanjing Kangni Smart Technology Co., Ltd. Oct 6, 2025 |
| K251565 — Wheelchair (N817) | Zhejiang Topwe Tools Manufacturing Co.,Ltd Oct 6, 2025 |
| K252140 — Heylo System | Coloplast Corp. Oct 6, 2025 |
| K251603 — Tigertriever 17 Ultra Revascularization Device | Rapid Medical Ltd. Oct 6, 2025 |
| K252007 — BlineSlide | Deep Breathe, Inc. Oct 6, 2025 |
| DEN240073 — PainChek (PainChek Adult) | Painchek Limited (Ltd.) Oct 6, 2025 |
| 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 Oct 6, 2025 |
| K251464 — TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit) | Jeisys Medical Incorporated Oct 3, 2025 |
| DEN220077 — ProSense System | Icecure Medical Oct 3, 2025 |
| K251426 — da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. Oct 3, 2025 |
| 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 Oct 3, 2025 |
| K250031 — Amplatzer Guidewire | ABBOTT MEDICAL Oct 3, 2025 |
| K243968 — Revolve Surgical System | Revolve Surgical, Inc. Oct 3, 2025 |
| K250028 — Anti Snore Mouthpiece | Dongguan Yiyao Science & Technology Development Co., Ltd. Oct 3, 2025 |
| K252178 — MAGENTIQ-COLO (ME-APDS) | Magentiq Eye, Ltd. Oct 3, 2025 |
| K250039 — HPACS | Healthhub Oct 3, 2025 |