| K253242 — LCD Monitor (C1216W, C822W, C821W) | Shenzhen Beacon Display Technology Co., Ltd. Oct 29, 2025 |
| K252376 — Yomi S Robotic System | Neocis, Inc. Oct 28, 2025 |
| K252351 — UniSpace® TPLIF Cage | Cg Medtech Co., Ltd. Oct 28, 2025 |
| K252547 — TheraSphere 360 Y-90 Management Platform | Boston Scientific Corporation Oct 28, 2025 |
| K253399 — Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter | Volcano Corporation (Dba Philips Image Guided Therapy Device Oct 28, 2025 |
| K252165 — ZIRCONOMER P | Shofu Dental Corporation Oct 28, 2025 |
| K251466 — VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr | Wellell, Inc. Oct 28, 2025 |
| K250275 — PrecisePath Radiofrequency Puncture Generator and PrecisePath Footswitch | Baylis Medical Technologies, Inc. Oct 28, 2025 |
| K253300 — Fine Osteotomy | Bodycad Laboratories, Inc. Oct 28, 2025 |
| K252742 — Navigated Instruments | Tyber Medical, LLC Oct 28, 2025 |
| K250297 — TECHFIT Patient-Specific Cranial System | Techfit Digital Surgery, Inc. Oct 27, 2025 |
| K251027 — cvi42 Coronary Plaque Software Application | Circle Cardiovascular Imaging, Inc. Oct 27, 2025 |
| K252629 — Electric Breast Pump (HL-3058, F5112) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. Oct 27, 2025 |
| K251875 — LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system | Affinity Biosensors, LLC Oct 27, 2025 |
| K251824 — Patriot Duo | Patriot Laser, LLC Oct 27, 2025 |
| K252467 — Disposable Vinyl Examination Gloves | Viet Phu Trade And Import Export Co., Ltd. Oct 27, 2025 |
| K250520 — OsteoCentric Navigated Instruments System | Osteocentric Technologies, Inc. Oct 27, 2025 |
| K251331 — Blood Pressure Monitor (B73, BE23T) | Shenzhen Jamr Technology Co., Ltd. Oct 27, 2025 |
| K252053 — VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F) | Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd Oct 27, 2025 |
| K252630 — Electric Breast Pump (HL-3060, F5113) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. Oct 27, 2025 |
| K251710 — Mobile X-ray unit (!M1) | Solutions For Tomorrow AB Oct 24, 2025 |
| K251372 — VersaD Delivery Catheter | Unity Medical, Inc. Oct 24, 2025 |
| K253125 — Parietene Flat Sheet Mesh | Medtronic - Sofradim Production Oct 24, 2025 |
| K253106 — AngioVac Cannula | AngioDynamics, Inc. Oct 24, 2025 |
| K250345 — Medline Bag Decanter | Medline Industries, LP Oct 24, 2025 |
| K253188 — CoaguChek XS Plus System | Roche Diagnostics Oct 24, 2025 |
| K250696 — AccuCheck | Manteia Technologies Co., Ltd. Oct 24, 2025 |
| K252645 — LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub | Philips Medical Systems Nederland B.V. Oct 24, 2025 |
| K253129 — Infinity OCT System | Medtronic Sofamor Danek USA, Inc. Oct 24, 2025 |
| K251312 — Vesalio Peripheral System | Vesalio, Inc. Oct 24, 2025 |
| K251974 — Arctic Sun Temperature Management System (Model 5000) | Medivance, Inc. Oct 24, 2025 |
| K252044 — Triathlon® Total Knee System - Triathlon® Gold Femoral Components | Howmedica Osteonics Corp., Dba Stryker Orthopaedics Oct 24, 2025 |
| K251059 — Syngo Carbon Clinicals (VA41) | Siemens Healthineers AG Oct 24, 2025 |
| K251784 — Hushd Pro Z-Link | Good Sleep CO Pte , Ltd. Oct 24, 2025 |
| K252730 — Fule Spinal Fixation System | Beijing Fule Science & Technology Development Co., Ltd. Oct 24, 2025 |
| K252646 — Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) | Olympus Medical Systems Corp. Oct 24, 2025 |
| K253335 — CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. Oct 24, 2025 |
| K252238 — CoroFlow Cardiovascular System | Coroventis Research AB Oct 24, 2025 |
| K253150 — Cryon-X Cold Compression | Jkh Health Co., Ltd. Oct 24, 2025 |
| K253377 — Expandable Titanium PLIF/TLIF System | Spectrum Spine, Inc. Oct 24, 2025 |
| K250904 — Atalante X | Wandercraft SAS Oct 24, 2025 |
| K250687 — Cocoon Solo (DX-7020s) | Dexcowin Global, Inc. Oct 24, 2025 |
| K251827 — Azurion R3.1 | Philips Medical Systems B.V. Oct 24, 2025 |
| K252357 — Glucose2 | Abbott Ireland Oct 24, 2025 |
| K252732 — 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. Oct 23, 2025 |
| K252345 — Picosecond Laser Device (PF131-BI) | Risu Medical Technology Co., Ltd. Oct 23, 2025 |
| 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. Oct 23, 2025 |
| K252425 — Silatrix Oral Gel | Sa3, LLC Oct 23, 2025 |
| K252309 — PerQseal Introducers | Vivasure Medical Limited Oct 23, 2025 |
| K253100 — MultiPulse TFL | Asclepion Laser Technologies GmbH Oct 23, 2025 |