| K250334 — Fusion Craniofacial Implant; Fusion Skull Implant | Kelyniam Global, Inc. Jul 25, 2025 |
| K250552 — Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire | ABBOTT MEDICAL Jul 25, 2025 |
| K250244 — Compression Therapy Device (LGT-2210DS) | Guangzhou Longest Medical Technology Co., Ltd. Jul 25, 2025 |
| K243244 — Heated Breathing Tube | Guangdong Eda Technology Co., Ltd. Jul 25, 2025 |
| K250859 — TransForm McCarthy Mitral Annuloplasty Ring (TF) | Genesee Biomedical, Inc. Jul 25, 2025 |
| K251620 — A.L.P.S. Proximal Humerus Plating System | Zimmer Biomet Jul 25, 2025 |
| K251665 — Triathlon® Hinge Knee System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics Jul 25, 2025 |
| K250989 — Stryker and Serf hip devices | Howmedica Osteonics Corp (Dba Stryker Orthopaedics) Jul 25, 2025 |
| K250232 — Vathin® Video Bronchoscope System | Hunan Vathin Medical Instrument Co., Ltd. Jul 25, 2025 |
| K250970 — Marie | Leo Cancer Care Jul 25, 2025 |
| K243403 — BD Nexiva Closed IV Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. Jul 25, 2025 |
| K252033 — Profoject Disposable Syringe, Profoject Disposable Syringe with Needle | CMT Health PTE., Ltd. Jul 25, 2025 |
| K251297 — MIS LYNX Conical Connection Implant System | Dentsply Sirona, Inc. Jul 24, 2025 |
| K243711 — Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580); | Wuxi Hisky Medical Technologies Co., Ltd. Jul 24, 2025 |
| K250284 — TSK SELECT Needle | Tsk Laboratory, Japan Jul 24, 2025 |
| K251984 — Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU) | Shenzhen Ulike Smart Electronics Co., Ltd. Jul 24, 2025 |
| K243392 — Infusomat® Space Volumetric Infusion Pump Administration Sets | B.Braun Medical, Inc. Jul 24, 2025 |
| K251618 — MOTO Partial Knee System Extension | Medacta International S.A. Jul 24, 2025 |
| K252010 — SPY Laparoscope | Stryker Endoscopy Jul 24, 2025 |
| K250322 — Respond OC Conserving Regulator (130-0800) | Responsive Respiratory Jul 24, 2025 |
| K252056 — Isolator® Synergy EnCompass Clamp and Guide system (OLH, OSH, GPM100) | AtriCure, Inc. Jul 24, 2025 |
| K251955 — Onflex Mesh | Davol Inc., Subsidiary Of C. R. Bard, Inc. Jul 24, 2025 |
| K251455 — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC Jul 24, 2025 |
| K251968 — HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL | Instrumentation Laboratory (IL) Co. Jul 24, 2025 |
| K243681 — Neuro Insight V1.0 | Olea Medical S.A.S. Jul 23, 2025 |
| K251280 — DESS® Dental Implants | Terrats Medical SL Jul 23, 2025 |
| K243781 — HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2) | Edwards Lifesciences Jul 23, 2025 |
| K250716 — IMAGE ONE | Infomed Software, S.L. Jul 23, 2025 |
| K251073 — Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) | Innovasis, Inc. Jul 23, 2025 |
| K251265 — Resilience Fully Covered Esophageal Stent System | Merit Medical Systems, Inc. Jul 23, 2025 |
| K242615 — Intermittent pressure compression system (Compression Pump PT1005A; Leg Compression Cuffs; L-1001S, L-1001L, L-1001XL, L-1001XXL, L-1001XXXL) | Xiamen Taotao Technology Co., Ltd. Jul 23, 2025 |
| K251748 — MammoSTAR Biopsy Site Identifier | Carbon Medical Technologies, Inc. Jul 23, 2025 |
| K251213 — Da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. Jul 23, 2025 |
| K250280 — SD TL Implant System | Arum Dentistry Co., Ltd. Jul 23, 2025 |
| K250590 — MAGiC Sweep EP Mapping Catheter | Stereotaxis, Inc. Jul 23, 2025 |
| K243373 — Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511) | Vitrolife Sweden AB Jul 23, 2025 |
| K250211 — Yushan X-Ray Flat Panel Detector | Innocare Optoelectronics Corp. Jul 22, 2025 |
| K243415 — Granudacyn® Wound Irrigation Solution | P.G.F. Industry Solutions GmbH Jul 22, 2025 |
| K251300 — Plastic Surgical Kits | Dentsply Sirona, Inc. Jul 22, 2025 |
| K243432 — Vascular Navigation PAD 2.0; Navigation Software Vascular PAD | Brainlab AG Jul 22, 2025 |
| K243367 — Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle) | Minnesota Medical Technologies Jul 22, 2025 |
| K251505 — VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) | Alafair Biosciences Jul 22, 2025 |
| K244018 — Disposable Biopsy Needle | Zhejiang Curaway Medical Technology Co., Ltd. Jul 22, 2025 |
| K243566 — CardioTag | Cardiosense, Inc. Jul 22, 2025 |
| K251310 — OTS 25-L (100-5) | Ots Medical , Ltd. Jul 22, 2025 |
| K251616 — Clear Miracle | Ods Co., Ltd. Jul 22, 2025 |
| K251638 — Mobility Scooter (MS160C) | Suzhou Master Machinery Manufacturing Co.,Ltd Jul 22, 2025 |
| K250901 — Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation Jul 22, 2025 |
| K250686 — GyriCalc (Version 1.0.0) | Neurospectrum Insights Corp. Jul 22, 2025 |
| K251255 — LymphaTech Mobile 3D Measuring Tool | Lymphatech, Inc. Jul 22, 2025 |