| K243692 — EnDrive (EnDriveUS) | Advanced Technology Research (A.T.R.) S.R.L. Aug 22, 2025 |
| K243685 — MammoScreen BD | Therapixel Aug 22, 2025 |
| K251443 — PROMO | DRGEM Corporation Aug 22, 2025 |
| K243965 — Origin | Nerv Technology Inc. (D.B.A.) Fluidai Medical Aug 21, 2025 |
| K251647 — MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System | Dentsply Sirona, Inc. Aug 21, 2025 |
| K250784 — Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122) | Shenzhen Yicai Health Technology Co., Ltd. Aug 21, 2025 |
| K251029 — Vista OS, Vista AI Scan, RTHawk | Vista AI, Inc. Aug 21, 2025 |
| K250923 — Fine Osteotomy | Bodycad Laboratories, Inc. Aug 21, 2025 |
| K251130 — Portable Oxygen Concentrator (JM-P50A) | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. Aug 21, 2025 |
| K251135 — Treace Medical Concepts (TMC) Implant Fixation System | Treace Medical Concepts Aug 21, 2025 |
| K251579 — VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) | bioMerieux, Inc. Aug 21, 2025 |
| K251588 — LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) | Shenzhen Fittop Health Technology Co., Ltd. Aug 21, 2025 |
| K252356 — The Acumed Wrist Fixation System - 2.4mm Screws | Acumed, LLC Aug 21, 2025 |
| K252244 — Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid | Ever Global (Vietnam) Enterprise Corporation Aug 21, 2025 |
| K241152 — InSee | Tidal Medical Technologies, LLC Aug 21, 2025 |
| K250994 — ClearTip FNA and FNB Types | Finemedix Co., Ltd. Aug 21, 2025 |
| K251400 — T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System | Stryker GmbH Aug 20, 2025 |
| K251580 — MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) | Liofilchem S.R.L. Aug 20, 2025 |
| DEN250002 — Delphi-MD System | Quantalx Neuroscience, Ltd. Aug 20, 2025 |
| K250417 — Remanufactured EndoWrist Cobra Grasper (420190) | Rebotix Aug 20, 2025 |
| K252061 — Distal Xtremities System | TriMed, Inc. Aug 20, 2025 |
| K251590 — Methinks CTA Stroke | Methinks Software, S.L Aug 20, 2025 |
| 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 |