FDA 510(k) Search and Medical Device Explorer
Search and browse FDA-cleared medical devices, 510(k) submissions, De Novo classifications, PMA records, product codes, review panels, and 21 CFR regulation groupings.
Review Panels
- Anesthesiology (AN)
- Clinical Chemistry (CH)
- Cardiovascular (CV)
- Dental (DE)
- Ear, Nose, Throat (EN)
- Gastroenterology, Urology (GU)
- Hematology (HE)
- General Hospital (HO)
- Immunology (IM)
- Medical Genetics (MG)
- Microbiology (MI)
- Neurology (NE)
- Obstetrics/Gynecology (OB)
- Ophthalmic (OP)
- Orthopedic (OR)
- Pathology (PA)
- Physical Medicine (PM)
- Radiology (RA)
- General, Plastic Surgery (SU)
- Clinical Toxicology (TX)
Recent Decisions
| Record | Device | Applicant | Decision Date |
|---|---|---|---|
| K260369 | Dynamis Robotic Surgical System | LEM Surgical AG | Jun 20, 2026 |
| K261713 | Synapse PACS (7.6.0) | FUJIFILM Healthcare Americas Corporation | Jun 18, 2026 |
| K261707 | MEMO 4D Curve™ Semirigid mitral annuloplasty ring | Corcym S.r.l. | Jun 18, 2026 |
| K261701 | Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8) | Micro-Energy Medical Technology Co., Ltd. | Jun 18, 2026 |
| K261665 | CORUS™ Navigation System-GN | Providence Medical Technology, Inc. | Jun 18, 2026 |
| K261651 | Precice™ Max System and Precice™ Ankle Salvage System | NuVasive Specialized Orthopedics | Jun 18, 2026 |
| K261246 | SRGC-06 | GC America, Inc. | Jun 18, 2026 |
| K261099 | Blood Volume Analyzer (200) | Daxor Corporation | Jun 18, 2026 |
| K260946 | LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) | Guangdong Newdermo Biotech Co., Ltd. | Jun 18, 2026 |
| K260820 | VIVIX-S 4386W (FXRD-4386WA) | Vieworks Co., Ltd. | Jun 18, 2026 |
| K260729 | Vascular Assist Occlusion Triage (VAOT) (v1.0) | GuideAI Health | Jun 18, 2026 |
| K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating | Stryker Sustainability Solutions | Jun 18, 2026 |
| K260280 | NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture Reagent F023, Crab (Callinectes spp.); Capture Reagent F079, Gluten, Wheat; Capture Reagent F202, Cashew Nut (Anacardium occidentale); Capture Reagent F233, Gal d 1 Ovomucoid Egg | Hycor Biomedical | Jun 18, 2026 |
| K260190 | ARTHUR | ROPCA ApS | Jun 18, 2026 |
| K260178 | Pelvic Muscle Trainer (KM510, KM516B) | Shenzhen Konmed Technology Co., Ltd. | Jun 18, 2026 |
| K254254 | Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) | Shenzhen Root Innovation Technology Co., Ltd. | Jun 18, 2026 |
| K254169 | SmartSpectra Vital Signs Monitor 1.0 | Presage Security, Inc. d/b/a Presage Technologies, Inc. | Jun 18, 2026 |
| K253824 | Powder Free Nitrile Examination Gloves Non-Sterile Black | Kanglongda Vietnam Protection Technology Company Limited | Jun 18, 2026 |
| K253812 | Power Wheelchair (W5915B, W5915C, W5915D) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | Jun 18, 2026 |
| K253776 | Implantmed Plus II & Piezomed Plus II Module | W&H Dentalwerk Buermoos GmbH | Jun 18, 2026 |
| K253678 | MAMMOMAT B.brilliant (11372950) | Siemens Medical Solutions USA, Inc. | Jun 18, 2026 |
| K253521 | ECMT-100 WMD | Ecm Therapeutics, Inc. | Jun 18, 2026 |
| K253187 | SteriBest® Sterilization Tray System | Mastel Surgical | Jun 18, 2026 |
| K253131 | Curing Light (M-Cure 6) | Guangzhou Rebornendo Medical Instrument Co., Ltd. | Jun 18, 2026 |
| K253126 | Wrist Blood Pressure Monitor (XW-05) | Shenzhen Ziqing Medical Equipment Co., Ltd. | Jun 18, 2026 |
| K253116 | 3D MAC Titanium Cranial Plate (TCP) System | The Surgeon General, Department of the Army (TSG-DA) | Jun 18, 2026 |
| K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe | Sol-Millennium Medical, Inc. | Jun 18, 2026 |
| K253080 | AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02) | Suzhou and Science & Technology Development Corp. | Jun 18, 2026 |
| K253058 | Portable DR Imaging System | Shantou Institute of Ultrasonic Instruments Co., Ltd. | Jun 18, 2026 |
| K253050 | RadOncAI | Informai | Jun 18, 2026 |
