| K252104 — T1D1 | Comerge AG Aug 20, 2025 |
| K251229 — EndoFixTissue Fixation System | Softac Medical Technologies Aug 20, 2025 |
| K251481 — ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. Aug 20, 2025 |
| K243804 — MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan) | Beckman Coulter, Inc. Aug 20, 2025 |
| K251471 — IPD Dental Implant Abutments | Implant Protesis Dental 2004, S.L. Aug 20, 2025 |
| K250721 — LOCATOR® Angled Abutment | Zest Anchors, LLC Aug 20, 2025 |
| K251837 — Salix Coronary Plaque (V1.0.0) | Artrya Limited Aug 20, 2025 |
| K251563 — WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test | Wondfo USA Co, Ltd. Aug 20, 2025 |
| K250383 — Wearable Breast Pump (Model W6) | Shenzhen TPH Technology Co., Ltd. Aug 20, 2025 |
| K250399 — Remanufactured EndoWrist Cadiere Forceps (420049) | Rebotix Aug 19, 2025 |
| K250539 — Remanufactured EndoWrist Tenaculum Forceps (420207) | Rebotix Aug 19, 2025 |
| K250313 — Sterile Powder Free Synthetic Rubber Surgeons Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid | Harps Europe Manufacturing GmbH Aug 19, 2025 |
| K252022 — OSSIOfiber® Interference Screw | OSSIO , Ltd. Aug 19, 2025 |
| K250387 — Remanufactured EndoWrist Long Tip Forceps (420048) | Rebotix Aug 19, 2025 |
| K243713 — Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A) | Agnes Medical Co., Ltd. Aug 19, 2025 |
| K252316 — Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100) | Venclose, Inc. Aug 19, 2025 |
| K243539 — Apollo TMS Therapy System | Mag & More GmbH Aug 18, 2025 |
| K243604 — Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid | O&M Halyard, Inc. Aug 18, 2025 |
| K251161 — ANTHEM® Fracture System | Globus Medical, Inc. Aug 18, 2025 |
| K251086 — PnueAira (PNCU-01) | Biotab, LLC Aug 18, 2025 |
| K250167 — Evolution Spine Navigation Instruments | Evolution Spine Aug 18, 2025 |
| K250271 — Neodent Implant System - Zirconia Implant System | JJGC Indústria E Comércio De Materiais Dentários S.A. Aug 18, 2025 |
| K251913 — OsteoCentric® UnifiMI® TCS Plating System | OsteoCentric Technologies Aug 16, 2025 |
| K243851 — CHLOE BLAST | Fairtility , Ltd. Aug 15, 2025 |
| K251834 — Persona Partial Knee | Zimmer Biomet Aug 15, 2025 |
| K251972 — Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180) | Healgen Scientific,, LLC Aug 15, 2025 |
| K251243 — OneRF Trigeminal Nerve Radiofrequency Probes | Neuroone Medical Technologies Corp. Aug 15, 2025 |
| K250170 — PHAROS | Brightonix Imaging Aug 15, 2025 |
| K251871 — FEATHER 01 02 03 04 (Model:01) | Heat IN A Click, LLC Aug 15, 2025 |
| K252236 — CP Relief Wand Rx - TENS/NMES | N & C Holdings, LLC Aug 15, 2025 |
| K250620 — KLS Martin Ixos System | KLS Martin L.P. Aug 15, 2025 |
| K250818 — Nerveblox | Smart Alfa Teknoloji San. Ve Tic. A.S. Aug 15, 2025 |
| K243650 — Zio® monitor (DFG0001) | iRhythm Technologies, Inc. Aug 15, 2025 |
| K251969 — Atlas Spine Project X Expandable Posterior Lumbar Interbody System | Atlas Spine, Inc. Aug 15, 2025 |
| K251747 — VEA Align; spineEOS | Eos Imaging Aug 15, 2025 |
| K250036 — MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL) | Beckman Coulter, Inc. Aug 15, 2025 |
| K250397 — Helios Dermal Scaffold | Helios Biomedical, Inc. Aug 15, 2025 |
| K251877 — JMS CAVEO A.V. Fistula Needle Set | JMS North America Corporation Aug 15, 2025 |
| K252259 — AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup | Assure Tech., LLC Aug 15, 2025 |
| K250867 — Dunamis Screw and Suture Locking System | Dunamis Medical, LLC Aug 15, 2025 |
| K250898 — Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm); Reprocessed HARMONIC 700 Shears (HAR736/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 36cm); Reprocessed HARMONIC 700 Shears (HAR745/Reprocessed HARMONIC 700, 5mm Diameter SHears with Advanced Hemostasis x 45cm) | Stryker Sustainability Solutions Aug 14, 2025 |
| K251062 — Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi Pack | Geistlich Pharma AG Aug 14, 2025 |
| K250916 — WinForth (LM-E470KA) | Shenzhen Leaflife Technology Co., Ltd. Aug 14, 2025 |
| K251176 — IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A, T22B, T25B, T25C) | Shenzhen Mlay Intelligent Technology Co., , Ltd. Aug 14, 2025 |
| K250164 — Cassette Autoclave (ACA5) | Guangzhou Ajax Medical Equipment Co., Ltd. Aug 14, 2025 |
| K243544 — BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini | Biofire Diagnostics, LLC Aug 14, 2025 |
| K251526 — FilmArray GI Control Panel M238 | Maine Molecular Quality Controls, Inc. Aug 14, 2025 |
| K243437 — mOm Essential Incubator (ME1) | Mom Incubators Limited Aug 14, 2025 |
| K243905 — Stitch Cerclage Suture Tapes | GM Dos Reis Industria E Comercio Ltda. Aug 14, 2025 |
| K243600 — 3nethra neo HD FA; 3nethra neo HD | Forus Health Pvt.Ltd Aug 14, 2025 |