Stay ahead in healthcare innovation with the latest FDA-approved AI tools and updates. Explore expert insights, regulatory trends, and practical resources to navigate the evolving landscape of medical technology.
| Date of Final Decision | Submission Number | Device | Company | Panel (lead) | Primary product code |
|---|---|---|---|---|---|
| 2025-11-07 | K252041 | Fibresolve (with PCCP) | Imvaria, Inc. | RA | QWO |
| 2025-11-06 | K253478 | Motive Muscle Stimulator for Lower Back (OT01-1003) | Motive Health Inc. | ||
| 2025-11-03 | K250330 | 3mensio Workstation | Pie Medical Imaging B.V. | RA | QIH |
| 2025-10-31 | K252777 | Freedom Metaphyseal Cone Implants (Metaphyseal Cones) | Maxx Orthopedics, Inc. | OR | MBH |
| 2025-10-31 | K251547 | DESS Dental Smart Solutions | Terrats Medical SL | DE | NHA |
| 2025-10-30 | K250632 | Arctx Cool Catheter Set | Arctx Medical | CV | PLA |
| 2025-10-29 | K251985 | LOGIQ E10 | GE Medical Systems Ultrasound and Primary Care Diagnostics | RA | IYN |
| 2025-10-29 | K252416 | AETOS Shoulder System Meta Humeral Prosthesis Size 0 | Smith & Nephew, Inc. | OR | KWS |
| 2025-10-27 | K252467 | Disposable Vinyl Examination Gloves | Viet Phu Trade and Import Export Co., Ltd | HO | LYZ |
| 2025-10-17 | K250250 | ADVIA Centaur Anti-Thyroid Peroxidase II | Siemens Healthcare Diagnostics, Inc. | IM | JZO |
| 2025-10-17 | K250911 | MOSkin Radiation Measurement System | Electrogenics Labs, Ltd | RA | IYE |
| 2025-10-16 | K242100 | SurgiAid Collagen Wound Dressing (HA) | Maxigen Biotech Inc. | KGN | |
| 2025-10-12 | K251034 | Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare Wand (HD-44) | Shenzhen Nuon Medical Equipment Co., Ltd | NE | NFO |
| 2025-10-10 | K250249 | Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System | Gold Standard Diagnostics, LLC. | MI | GMQ |
| 2025-10-10 | K251835 | Yomi Robotic System | Neocis, Inc. | DE | PLV |
| 2025-10-10 | K252903 | Verruca-Freeze H Plus | CryoSurgery, Inc. | SU | GEH |
| 2025-10-09 | K252911 | Lux HD 2530 detector (Lux HD 2530) | iRay Imaging Technology (Haining) Limited | RA | MQB |
| 2025-10-09 | K251795 | Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753) | HONSUN (Nantong) Co.,Ltd. | CV | DXN |
| 2025-10-09 | K252867 | VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup | Advin Biotech, Inc. | TX | NFT |
| 2025-10-08 | K252766 | 14Fr Low Profile Introducer Kit | Abiomed Inc. | CV | DYB |