| K252376 — Yomi S Robotic System | Neocis, Inc. Tue Oct 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253300 — Fine Osteotomy | Bodycad Laboratories, Inc. Tue Oct 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252742 — Navigated Instruments | Tyber Medical, LLC Tue Oct 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251875 — LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system | Affinity Biosensors, LLC Mon Oct 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251027 — cvi42 Coronary Plaque Software Application | Circle Cardiovascular Imaging, Inc. Mon Oct 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252467 — Disposable Vinyl Examination Gloves | Viet Phu Trade and Import Export Co., Ltd. Mon Oct 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252629 — Electric Breast Pump (HL-3058, F5112) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. Mon Oct 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251824 — Patriot Duo | Patriot Laser, LLC Mon Oct 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250297 — TECHFIT Patient-Specific Cranial System | Techfit Digital Surgery, Inc. Mon Oct 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250520 — OsteoCentric Navigated Instruments System | Osteocentric Technologies, Inc. Mon Oct 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251331 — Blood Pressure Monitor (B73, BE23T) | Shenzhen Jamr Technology Co., Ltd. Mon Oct 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252053 — VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F) | Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd Mon Oct 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252630 — Electric Breast Pump (HL-3060, F5113) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. Mon Oct 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253188 — CoaguChek XS Plus System | Roche Diagnostics Fri Oct 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250696 — AccuCheck | Manteia Technologies Co., Ltd. Fri Oct 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252730 — Fule Spinal Fixation System | Beijing Fule Science & Technology Development Co., Ltd. Fri Oct 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253125 — Parietene Flat Sheet Mesh | Medtronic - Sofradim Production Fri Oct 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251784 — Hushd Pro Z-Link | Good Sleep CO Pte , Ltd. Fri Oct 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251372 — VersaD Delivery Catheter | Unity Medical, Inc. Fri Oct 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251312 — Vesalio Peripheral System | Vesalio, Inc. Fri Oct 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250345 — Medline Bag Decanter | Medline Industries, LP Fri Oct 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253106 — AngioVac Cannula | AngioDynamics, Inc. Fri Oct 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253129 — Infinity OCT System | Medtronic Sofamor Danek USA, Inc. Fri Oct 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252646 — Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) | Olympus Medical Systems Corp. Fri Oct 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251710 — Mobile X-ray unit (!M1) | Solutions For Tomorrow AB Fri Oct 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252044 — Triathlon® Total Knee System - Triathlon® Gold Femoral Components | Howmedica Osteonics Corp., Dba Stryker Orthopaedics Fri Oct 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251974 — Arctic Sun Temperature Management System (Model 5000) | Medivance, Inc. Fri Oct 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251059 — Syngo Carbon Clinicals (VA41) | Siemens Healthineers AG Fri Oct 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253335 — CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. Fri Oct 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252645 — LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub | Philips Medical Systems Nederland B.V. Fri Oct 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252238 — CoroFlow Cardiovascular System | Coroventis Research AB Fri Oct 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253150 — Cryon-X Cold Compression | Jkh Health Co., Ltd. Fri Oct 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253377 — Expandable Titanium PLIF/TLIF System | Spectrum Spine, Inc. Fri Oct 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250904 — Atalante X | Wandercraft SAS Fri Oct 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250687 — Cocoon Solo (DX-7020s) | Dexcowin Global, Inc. Fri Oct 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251827 — Azurion R3.1 | Philips Medical Systems B.V. Fri Oct 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252357 — Glucose2 | Abbott Ireland Fri Oct 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252732 — 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. Thu Oct 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252425 — Silatrix Oral Gel | Sa3, LLC Thu Oct 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252345 — Picosecond Laser Device (PF131-BI) | Risu Medical Technology Co., Ltd. Thu Oct 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252309 — PerQseal Introducers | Vivasure Medical Limited Thu Oct 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250861 — Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black) | Hartalega NGC Sdn. Bhd. Thu Oct 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253100 — MultiPulse TFL | Asclepion Laser Technologies GmbH Thu Oct 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252384 — DESS® Dental Smart Solutions | Terrats Medical SL Thu Oct 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250288 — TeraRecon Cardiovascular.Calcification.CT | Terarecon,Inc. Thu Oct 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253226 — UV5000W Handle | Uroviu Corporation Thu Oct 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252931 — Invisalign® Palatal Expander System | Align Technology, Inc. Thu Oct 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251977 — electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X) | Ningbo Youhe Electrical Appliance Technology Co., Ltd. Wed Oct 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252322 — SIros-X System | Genesys Spine Wed Oct 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252298 — ANDI 2.0 | Imeka Solutions, Inc. Wed Oct 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |