| K251011 — Chiavaye Personal Moisturizer | Unipack, LLC Dec 19, 2025 |
| K253616 — ProtekDilate Vascular Access Kit | Sorin Group Italia S.R.L. Dec 19, 2025 |
| K252976 — Park Dental Nylon MAD | Park Dental Research Corp. Dec 18, 2025 |
| K252402 — Midline Catheter | Terumo Medical Products (Hangzhou) Co., Ltd. Dec 18, 2025 |
| K252348 — Tomey Optical Biometer OA-2000 (OA-2000) | Tomey Corporation Dec 18, 2025 |
| K252793 — ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C) | Jiangsu Jiyuan Medical Technology Co., Ltd. Dec 18, 2025 |
| K252956 — Helo Thrombectomy System | Endovascular Engineering, Inc. Dec 18, 2025 |
| K252235 — PVAD IQ Software | Ultrasight , Ltd. Dec 18, 2025 |
| K253518 — FX CorAL 40; FX CorAL 50 | Fresenius Medical Care Renal Therapies Group, LLC Dec 18, 2025 |
| K252071 — RefleXion Medical Radiotherapy System, Reflexion X2 | Reflexion Medical, Inc. Dec 18, 2025 |
| K252533 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) | Edwards Lifesciences Dec 18, 2025 |
| K250914 — MediAI-BA | Crescom Co., Ltd. Dec 18, 2025 |
| K252320 — SIMDA Abutments | Simda Co., Ltd. Dec 18, 2025 |
| K253915 — MOVIVA® Hybrid Ablation Probe | Erbe Elektromedizin GmbH Dec 18, 2025 |
| K253758 — Dental Cone; Dental Sponge | Medizin Produkte Neustadt GmbH (Mpn) Dec 18, 2025 |
| K251562 — OTSCneo System Set (100.03n-14n, 100.27n-31n) | Ovesco Endoscopy AG Dec 18, 2025 |
| K253516 — Assert-IQ (DM5100) | ABBOTT MEDICAL Dec 18, 2025 |
| K250993 — Single Use Cytology Brush V (BC-V600P-3010) | Olympus Medical Systems Corporation Dec 18, 2025 |
| K251915 — Amethyst HP PTA OTW 0.035 Catheter | Natec Medical , Ltd. Dec 18, 2025 |
| K253093 — Vital Spinal Fixation System | Highridge Medical, LLC Dec 17, 2025 |
| K252922 — Neosoma Brain Mets | Neosoma, Inc. Dec 17, 2025 |
| K253719 — Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons | Unibeauty (Hubei) Technology Co., Ltd. Dec 17, 2025 |
| K252983 — Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03) | Shenzhen Goodwind Technology Development Co., Ltd. Dec 17, 2025 |
| K253710 — Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. Dec 17, 2025 |
| K252417 — Amplatzer Piccolo Delivery System (9-PDS-04F-045) | ABBOTT MEDICAL Dec 17, 2025 |
| K253721 — KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O Dec 17, 2025 |
| K253839 — Elecsys Anti-SARS-CoV-2 | Roche Diagnostics Dec 17, 2025 |
| K252739 — ETHICON 4000 45mm Compact Stapler (EC3DT45C); ETHICON 4000 45mm Standard Stapler (EC3DT45S); ETHICON 4000 45mm Long Stapler (EC3DT45L); ETHICON 3D 45mm White Reload (ER45W); ETHICON 3D 45mm Blue Reload (ER45B); ETHICON 3D 45mm Green Reload (ER45G); ETHICON 3D 45mm Black Reload (ER45T) | Ethicon Endo-Surgery, LLC Dec 17, 2025 |
| K252518 — DuoprossTM Smart Cap (Type I) | Duopross Meditech Corporate Dec 17, 2025 |
| K252191 — BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System | Bonebridge AG Dec 17, 2025 |
| K251416 — UltraSight Guidance | Ultrasight , Ltd. Dec 17, 2025 |
| K252398 — SURFLO Hybria Closed System Safety IV Catheter | Terumo Medical Products (Hangzhou) Co., Ltd. Dec 17, 2025 |
| K252508 — Intri26 Introducer Sheath | Inari Medical, Inc. Dec 17, 2025 |
| K250854 — Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro) | Shenzhen Comen Medical Instruments Co.,Ltd Dec 17, 2025 |
| K250925 — ADVIA Centaur Cytokeratin Fragment 21-1 | Fujirebio Diagnostics,Inc. Dec 16, 2025 |
| K252919 — IDENTIFY (5.0) | Varian Medical Systems, Inc. Dec 16, 2025 |
| K251771 — Cambridge Partial Knee | Signature Orthopaedics Pty, Ltd. Dec 16, 2025 |
| K251256 — PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family) | Pentax Of America, Inc. Dec 16, 2025 |
| K252373 — BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology | Spectrum Vascular Dec 16, 2025 |
| K253118 — Companion Spine DIAM Instrumentation | Companion Spine France Dec 16, 2025 |
| K251763 — IRISeg | Intuitive Surgical, Inc. Dec 16, 2025 |
| K253620 — TroClose 1200 | Gordian Surgical, Ltd. Dec 16, 2025 |
| K251745 — Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) | Baxter Healthcare Corporation Dec 16, 2025 |
| K252204 — prolaio eVO2peak Module (Version 1.0) | Prolaio, Inc. Dec 16, 2025 |
| K252268 — V series portable oxygen concentrator (V5, V5C, V6, V6C) | Shenzhen Harveymed Technology Co., Ltd. Dec 16, 2025 |
| K252468 — Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121) | Zhejiang Geyi Medical Instrument Co., Ltd. Dec 16, 2025 |
| K252111 — Versius Surgical System (Versius Plus) | Cmr Surgical Limited Dec 16, 2025 |
| K252940 — VR® Personal Protective Level 3 Gown (VR Gowns) | PolyConversions, Inc. Dec 16, 2025 |
| K251893 — SKAN C PULSAR | Skanray Technologies Limited Dec 16, 2025 |
| K251951 — Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Processor (RP-IPD-V2000EF); Endoscopic Video Image Processor (RP-IPD-V1000F) | Guangzhou Red Pine Medical Instrument Co., Ltd. Dec 16, 2025 |