| 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 |
| K252384 — DESS® Dental Smart Solutions | Terrats Medical SL Oct 23, 2025 |
| K250288 — TeraRecon Cardiovascular.Calcification.CT | Terarecon,Inc. Oct 23, 2025 |
| K253226 — UV5000W Handle | Uroviu Corporation Oct 23, 2025 |
| K252931 — Invisalign® Palatal Expander System | Align Technology, Inc. Oct 23, 2025 |
| K251185 — Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020) | Intervene Oct 22, 2025 |
| K252322 — SIros-X System | Genesys Spine Oct 22, 2025 |
| K252298 — ANDI 2.0 | Imeka Solutions, Inc. Oct 22, 2025 |
| K251749 — Flowflex Plus RSV + Flu A/B + COVID Home Test | ACON Laboratories, Inc. Oct 22, 2025 |
| K253145 — Pre-Sutured Tendon | Rti Surgical, Inc. Oct 22, 2025 |
| K252325 — Hair Growth Laser Cap | Cosmo Far East Technology Limited Oct 22, 2025 |
| K251977 — electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X) | Ningbo Youhe Electrical Appliance Technology Co., Ltd. Oct 22, 2025 |
| K251628 — Mandibular Advancement Device L07 | Dcstar, Inc. Oct 22, 2025 |
| K253147 — FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft Substitute FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute FIBERGRAFT BG Matrix Bone Graft Substitute | Prosidyan, Inc. Oct 22, 2025 |
| K250666 — Alegria Flash CTD Screen | Zeus Scientific Oct 22, 2025 |
| K253144 — Freedom® Total Knee System Titan PCK Components | Maxx Orthopedics, Inc. Oct 22, 2025 |
| K251030 — Sirona Advanced Imaging Suite | Sirona Medical Oct 22, 2025 |
| K252329 — QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B | QIAGEN GmbH Oct 22, 2025 |
| K250955 — XC11 ICE System, USA | Yorlabs, Inc. Oct 22, 2025 |
| K251663 — Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) | Datex-Ohmeda, Inc. Oct 22, 2025 |
| K252569 — Carrier XL Delivery Catheter | Balt USA, LLC Oct 22, 2025 |
| K251289 — WELLlife COVID-19 Antigen Test Rx | Guangzhou Wondfo Biotech Co., Ltd. Oct 22, 2025 |
| K250394 — Fine TTO | Bodycad Laboratories, Inc. Oct 21, 2025 |