| K250435 — Dexter L6 System | Distalmotion SA May 27, 2025 |
| K242820 — Puritan PurSafe Plus Collection and Transport System | Puritan Medical Products, LLC May 27, 2025 |
| K250384 — IPL400 | El Global Trade, Ltd. May 23, 2025 |
| K243023 — WiZARD 520 Full Face Mask | Wellell, Inc. May 23, 2025 |
| K251211 — ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocessed ICE Catheter; Advisor HD Grid Mapping Catheter, Sensor Enabled; Advisor HD Grid X Mapping Catheter, Sensor Enabled; Agilis NxT Steerable Introducer; Agilis NxT Steerable Introducer Dual-Reach | ABBOTT MEDICAL May 23, 2025 |
| K250549 — Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit | The Binding Site Group , Ltd. May 23, 2025 |
| K242594 — DEEPECHO | Deepecho May 23, 2025 |
| K243989 — Second Opinion® 3D | Pearl, Inc. May 23, 2025 |
| K242575 — Stereotaxic Guiding Surgical Devices, NaoTrac S | Brain Navi Biotechnology Co., Ltd. May 23, 2025 |
| K250938 — Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK;UI04S PP, UI04S BU, UI04S WH, UI04S PN) | Shenzhen Ulike Smart Electronics Co., Ltd. May 23, 2025 |
| K244047 — Navi Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) | Venocare, Inc. May 23, 2025 |
| K250446 — Frida Anterior Cervical Plate System | Spineup, Inc. May 23, 2025 |
| K242545 — RadiForce MX317W-PA | Eizo Corporation May 23, 2025 |
| K250544 — Knotilus+ Biocomposite Knotless Anchor | Stryker Endoscopy May 23, 2025 |
| K250778 — Sil-Flow | Dsi Dental Solutions, Ltd. May 23, 2025 |
| K250239 — NeuroMatch | LVIS Corporation May 23, 2025 |
| K243937 — Accuro 3S | Rivanna Medical, Inc. May 23, 2025 |
| K250005 — Clever One | Ewoosoft Co., Ltd. May 23, 2025 |
| K243474 — MagnetOs MIS | Kuros Biosciences B.V May 23, 2025 |
| K250361 — SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1 | Geske Beauty Tech GmbH May 23, 2025 |
| K251292 — RECLAIM Monobloc Revision Femoral Stem | Depuy Ireland UC May 23, 2025 |
| K251044 — 93 NeuFlex Catheter | Piraeus Medical May 23, 2025 |
| K243261 — FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L | Fujifilm Corporation May 23, 2025 |
| K250935 — TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw) | TriMed, Inc. May 22, 2025 |
| K242586 — ArgoCap (200.52) | Ovesco Endoscopy AG May 22, 2025 |
| K250878 — YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. May 22, 2025 |
| K250630 — Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate | Basic Medical Technology, Inc. May 22, 2025 |
| K250920 — Arthrex Spine Compression FT Screw | Arthrex, Inc. May 22, 2025 |
| K250639 — DESS Dental Smart Solutions | Terrats Medical SL May 22, 2025 |
| K251493 — Skin Clinic Freeze Point for Warts and Skin Tags | Cryoconcepts LP May 22, 2025 |
| K250980 — Physica System (Physica CR Porous Femoral components) | Lima Corporate S.P.A. May 22, 2025 |
| K251052 — Trivicta® Hip Stem | Ortho Development Corp. May 22, 2025 |
| DEN240035 — ConcizuTrace ELISA | Randox Laboratories, Ltd. May 22, 2025 |
| K242659 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL | Thermo Fisher Scientific May 22, 2025 |
| K242684 — Harioculture TL-16 Time-lapse Incubator | Hua Yue Medical Technology Co., Ltd. May 22, 2025 |
| K250910 — Optilume® High Pressure Urological Balloon Dilation Catheter | Urotronic, Inc. May 22, 2025 |
| K250532 — Solawave 2-in-1 Skincare Mini (Model: 61043) | Shenzhen Kaiyan Medical Equipment Co., Ltd. May 22, 2025 |
| K250897 — Koala Intrauterine Pressure Catheter (IPC-5000E) | Clinical Innovations, LLC May 22, 2025 |
| K243793 — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC May 21, 2025 |
| K250798 — Control-IQ+ technology | Tandem Diabetes Care, Inc. May 21, 2025 |
| K250493 — MotiliCap GI Monitoring System | Anx Robotica Corporation May 21, 2025 |
| K242857 — ClearHemograsper | Finemedix Co., Ltd. May 21, 2025 |
| K250528 — Stryker AlphaVent Knotless SP Biocomposite Anchor | Stryker Endoscopy May 21, 2025 |
| K243866 — InVision Precision Cardiac Amyloid | InVision Medical Technology Corporation May 21, 2025 |
| K251239 — GrandioSO Unlimited | Voco GmbH May 21, 2025 |
| K243122 — uMR Omega | Shanghai United Imaging Healthcare Co., Ltd. May 21, 2025 |
| K243429 — HJY VisualNext 3D Endoscopic Vision System | Hjy Smart Medical Device Co., Ltd. May 21, 2025 |
| K251109 — SMARTDent | Ray Co., Ltd. May 21, 2025 |
| K243116 — FlareHawk Interbody Fusion System | Integrity Implants Inc. Dba Accelus May 21, 2025 |
| K243762 — Synapse 3D Base Tools (V7.0) | Fujifilm Corporation May 21, 2025 |