| K253925 — Aventus Thrombectomy System | Inquis Medical Thu Jan 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252934 — Diagnocat | DGNCT, LLC Thu Jan 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253276 — Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02) | Shanghai Bangbang Robotics Co., Ltd. Thu Jan 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251847 — Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask | Sleepnet Corporation Thu Jan 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253470 — MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894) | Medtronic Minimed, Inc. Thu Jan 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251458 — Electric Wheelchair (DH01168) | Foshan Dahao Medical Technology Co., Ltd. Thu Jan 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254190 — dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T | Philips Medical Systems Nederland B.V. Wed Jan 14 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251419 — Laboratorios Biogalenic Sterile Water for Inhalation, USP | Laboratorios Biogalenic S.A. DE C.V. Wed Jan 14 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252313 — Cardinal Health Nitrile Examination Gloves Extended Cuff | Cardinalhealth Wed Jan 14 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251996 — ENTire IRE System | Entire Medical , Ltd. Wed Jan 14 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252219 — Cervical Interbody and VBR Fusion System | Sync Surgical Wed Jan 14 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252958 — METICULY Patient-specific titanium mesh implant | Meticuly Co., Ltd. Wed Jan 14 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253585 — SmartGuard technology; Predictive Low Glucose technology | Medtronic Minimed, Inc. Wed Jan 14 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253511 — Concerto Versa Detachable Coil | Medtronic, Inc. Wed Jan 14 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252579 — Orthoscan TAU MVP Mini C-Arm System | Ziehm-Orthoscan, Inc. Wed Jan 14 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254010 — ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface | Brainlab SE Wed Jan 14 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254014 — Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control | Stryker Endoscopy Tue Jan 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251214 — BEAR® (Bridge-Enhanced ACL Restoration) Implant | Miach Orthopaedics, Inc. Tue Jan 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252549 — Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid | Kossan International Sdn Bhd Tue Jan 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253248 — Bright Cavity Liner | Dmp Dental Industry S.A. Tue Jan 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252461 — Swedge Pedicle Screw Fixation System Bezier Rod | Spinal Resources, Inc. Tue Jan 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254001 — VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) | Spectrum Dynamics Medical, Ltd. Tue Jan 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251307 — Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) | Shenzhen Hingmed Medical Instrument Co., Ltd. Mon Jan 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251389 — High speed air turbine handpiece | Foshan Topmed Dental Co., Ltd. Mon Jan 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252807 — Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates | Arthrex, Inc. Mon Jan 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251886 — EmpowerRide NAVIGATOR | Empower Ride, LLC Mon Jan 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251701 — Star E900 Electric System | Dentalez, Inc., Stardental Division Mon Jan 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252830 — Disposable Surgical Face Mask (3P00B, C2900) | Beatles Medical Supplies (Xiantao) Co., Ltd. Mon Jan 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252913 — Break Wave | Sonomotion, Inc. Mon Jan 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251988 — Boston iFace (Boston iFace) | Boston Aesthetics, Inc. Mon Jan 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251524 — Dr. Yglo Skin Tag Remover | Theotclab Healthcare B.V. Mon Jan 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252962 — DYNAMIS Navigation System | Promethean Restorative, LLC Mon Jan 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250890 — SBC1 Cream | Sioxmed, LLC Mon Jan 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251558 — Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty, Ltd. Mon Jan 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251388 — Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41) | Foshan Topmed Dental Co., Ltd. Mon Jan 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253167 — Any-Paste | Mediclus Co., Ltd. Mon Jan 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252842 — SafeOp 3: Neural Informatix System | Alphatec Spine, Inc. Sun Jan 11 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253957 — HemosIL Silica Clotting Time | Instrumentation Laboratory (IL) Co. Fri Jan 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252339 — iotaSOFT® Insertion System | Iotamotion, Inc. Fri Jan 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252674 — Solo Pace Fusion System (SOLOFUSE1) | Solo Pace, Inc. Fri Jan 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254003 — JARVIS Metaphyseal Stem | FH Industrie Fri Jan 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253964 — Disposable Neonatal NIBP Cuff (U1681S-C51N) | Unimed Medical Supplies, Inc. Fri Jan 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253142 — Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D) | Ningbo Ranor Medical Technology Co., Ltd. Fri Jan 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251139 — KabiHelp® Uno; KabiHelp® Advance plus | Fresenius Kabi AG Fri Jan 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252906 — ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) | Ethicon Endo-Surgery, LLC Fri Jan 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252847 — NextAR Hip Platform | Medacta International S.A. Fri Jan 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253973 — Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series | Liaoning Upcera Co., Ltd. Fri Jan 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253550 — Self-Forming Magnet (Flexagon Plus OTOLoc) | GI Windows, Inc. Fri Jan 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252589 — Corvair Monza | AliveCor, Inc. Fri Jan 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251157 — Core Metabolic | Truvian Health Fri Jan 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |