| K251843 — Erchonia EVRL | Erchonia Corporation Sep 12, 2025 |
| K251320 — XTRA4 | Al.Chi.Mi.A. S.R.L Sep 11, 2025 |
| K250507 — Hypertension Notification Feature (HTNF) | Apple, Inc. Sep 11, 2025 |
| K251158 — PowerWire® 14 Radiofrequency Guidewire Kit | Baylis Medical Technologies, Inc. Sep 11, 2025 |
| K252520 — SEFRIA Hydrocodone Oral Fluid | Immunalysis Corporation Sep 11, 2025 |
| K250797 — UV5000 Handle | Uroviu Corporation Sep 11, 2025 |
| K251758 — Serafin® | Tns Co., Ltd. Sep 11, 2025 |
| K242314 — Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2) | Augment Intelligent Medical System (China) Co., Ltd. Sep 11, 2025 |
| K250216 — OsteoProbe (OP-100) | Active Life Scientific, Inc. Sep 11, 2025 |
| K252374 — Nylon flexTAP(R) | Airway Technologies D/B/A Airway Management Sep 11, 2025 |
| K251316 — Mazor X System / Mazor X Stealth Edition | Mazor Robotics , Ltd. Sep 11, 2025 |
| K243926 — Vivatmo pro-S | Bosch Healthcare Solutions GmbH Sep 11, 2025 |
| K251826 — RENASYS WOUND+ Dressing Kit with AIRLOCK Technology | Smith & Nephew Medical, Ltd. Sep 11, 2025 |
| K251399 — SIGNA Sprint | Ge Medical Systems, LLC Sep 11, 2025 |
| K252580 — iQ200 Series | Beckman Coulter, Inc. Sep 10, 2025 |
| K252173 — F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full | Fisher & Paykel Healthcare, Ltd. Sep 10, 2025 |
| K244002 — AngioWaveNet | Angiowave Imaging, Inc. Sep 10, 2025 |
| K252530 — OptiVu Shoulder | Mr Surgical Solutions, LLC Sep 10, 2025 |
| K250734 — OptiLUV Device | Pollogen, Ltd. Sep 10, 2025 |
| K252527 — Surfacer Inside-Out Access Catheter System | Merit Medical System, Inc. Sep 10, 2025 |
| K251573 — VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens | Vizionfocus, Inc. Sep 10, 2025 |
| K250464 — Enlight 2100 (TPL-E2103-0) | Timpel S.A. Sep 10, 2025 |
| K251817 — da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. Sep 10, 2025 |
| K250483 — PhotonBlade 3; PhotonBlade 3 Smoke Evacuation | Stryker Instruments Sep 9, 2025 |
| K252524 — Quadsense (Quadsense and Quadsense Pro) | Eventum Orthopaedics, Ltd. Sep 9, 2025 |
| K252477 — Hybrid Viewer (00859873006240) | Hermes Medical Solutions AB Sep 9, 2025 |
| K251682 — MuscleView 2.0 | Springbok, Inc. (Dba Springbok Analytics) Sep 9, 2025 |
| K251891 — Electric Wheelchair (GY-E001) | Shandong Guyue Healthcare Appliance Co., Ltd. Sep 9, 2025 |
| K251773 — Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin Gel Caramel flavor lubricant; Satin Gel Peach flavor lubricant; Satin Gel Strawberry flavor lubricant.) | Shenzhen Yongquan Medical Devices Co., Ltd. Sep 9, 2025 |
| K252608 — AI-Rad Companion Prostate MR | Siemens Healthcare GmbH Sep 9, 2025 |
| K243846 — Access anti-HAV | Beckman Coulter, Inc. Sep 9, 2025 |
| K251040 — MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test | Guangzhou Decheng Biotechnology Co., Ltd. Sep 9, 2025 |
| K251072 — Segmentron Viewer | DGNCT, LLC Sep 9, 2025 |
| K250922 — Edema Guard Monitor (EGM) CardioSet-001 | Cardioset Medical , Ltd. Sep 9, 2025 |
| K252181 — AquaA | Fresenius Medical Care North America Sep 9, 2025 |
| K252180 — Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W) | Fresenius Medical Care Renal Therapies Group, LLC Sep 9, 2025 |
| K251227 — da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. Sep 8, 2025 |
| K251892 — MAXXOS P.A.C.E. Foot & Ankle Plating System | Maxxos Medical GmbH Sep 8, 2025 |
| K251610 — qER-CTA (v1.0) | Qure.Ai Technologies Sep 8, 2025 |
| K250928 — OmniTom Elite with PCD | Neurologica Corporation Sep 8, 2025 |
| K251754 — Wearable Breast Pump (Model S33) | Shenzhen TPH Technology Co., Ltd. Sep 8, 2025 |
| K251931 — BioTraceIO Vision (V1.7) | Techsomed Medical Technologies Sep 8, 2025 |
| K251394 — Momcozy Wearable Breast Pump (BP223) | Shenzhen Root Innovation Technology Co., Ltd. Sep 8, 2025 |
| K250229 — Dual Action Tissue Closure Device | Micro-Tech (Nanjing) Co., Ltd. Sep 8, 2025 |
| K251957 — Coaptium Connect with Tissium Light | Tissium SA Sep 8, 2025 |
| K250960 — DUO Microcatheter | Rev Neuro, LLC Sep 8, 2025 |
| K244038 — High Pressure Tubing | Shandong Int Medical Instruments Co., Ltd. Sep 5, 2025 |
| K250460 — WatchPAT400 (WP400) | Itamar Medical , Ltd. Sep 5, 2025 |
| K250095 — All-Suture Dual Anchor System | Suturetech, Inc. Sep 5, 2025 |
| K250132 — Ureteral Access Sheath | Zhejiang YiGao Medical Technology Co., Ltd. Sep 5, 2025 |