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 |
|---|---|---|---|
| K260563 | CN-Suite™ | FIND Surgical Sciences Inc. D/B/A FIND Neuro | Aug 16, 2026 |
| P230011S006 | TruSight Oncology Comprehensive | Illumina, Inc. | Aug 14, 2026 |
| K262639 | BAGUERA® C Cervical Disc Surgical Instruments | Spineart SA | Aug 14, 2026 |
| K262571 | EnCor EnCompass™ Breast Biopsy and Tissue Removal System | Bard Peripheral Vascular, Inc. | Aug 14, 2026 |
| K262552 | Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B) | Scivita Medical Technology Co., Ltd. | Aug 14, 2026 |
| K262452 | AutoContour (RADAC V6) | Radformation, Inc. | Aug 14, 2026 |
| K262449 | AdvaView | ADVAHEALTH SOLUTIONS, LLC | Aug 14, 2026 |
| K262424 | Willow 12 Guidewire | Arbor Endovascular, LLC | Aug 14, 2026 |
| K262419 | MICRUSFRAME (MFR100202); MICRUSFRAME (MFR100253); MICRUSFRAME (MFR100305); MICRUSFRAME (MFR100356); MICRUSFRAME (MFR100407); MICRUSFRAME (MFR100412); MICRUSFRAME (MFR100509); MICRUSFRAME (MFR100517); MICRUSFRAME (MFR100611); MICRUSFRAME (MFR100626); MICRUSFRAME (MFR100713); MICRUSFRAME (MFR100730); MICRUSFRAME (MFR100816); MICRUSFRAME (MFR100829); MICRUSFRAME (MFR140225); MICRUSFRAME (MFR140303); MICRUSFRAME (MFR140304); MICRUSFRAME (MFR140306); MICRUSFRAME (MFR140406); MICRUSFRAME (MF | Cerenovus, Inc. | Aug 14, 2026 |
| K261890 | 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D® | Boehringer Laboratories, LLC | Aug 14, 2026 |
| K261646 | Redermax® Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | Aug 14, 2026 |
| K261428 | NC Euphora Rapid Exchange Balloon Dilatation Catheter | Medtronic Ireland | Aug 14, 2026 |
| K261228 | QuickVision Ultimate rTMS | Brain Ultimate, Inc. | Aug 14, 2026 |
| K260898 | Transpara (2.1.0) | Screenpoint Medical B.V. | Aug 14, 2026 |
| K260559 | NHanceIT | IMDS Operation B.V. | Aug 14, 2026 |
| K260438 | Vital Signs Monitor (CLEO2) | Infinium Medical, Inc. | Aug 14, 2026 |
| K260374 | Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal | Empatica S.r.l. | Aug 14, 2026 |
| K260171 | Portable Oxygen Concentrator (PO1 5B, PO1 6B) | BMC Medical Co., Ltd. | Aug 14, 2026 |
| K253747 | Disposable Pen Injector (KXYC-03C02, KXYC-03A03) | Jiangsu Enjosim Medical Technology Co., Ltd. | Aug 14, 2026 |
| K253562 | medilogFD | Schiller AG | Aug 14, 2026 |
| K262398 | CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set | CERENOVUS, Inc. | Aug 13, 2026 |
| K261626 | UltraPrint Flexible Denture UV | Guangzhou Heygears IMC., Inc. | Aug 13, 2026 |
| K261499 | TrachFlush | Aw Technologies Aps | Aug 13, 2026 |
| K261139 | VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103) | Freyja Healthcare, LLC | Aug 13, 2026 |
| K261061 | BP Go (BPP-855) | Wellvii, Inc. | Aug 13, 2026 |
| K260907 | BIS™ Advance pEEG Module | Covidien LP | Aug 13, 2026 |
| K260413 | Levo Gen 2 Tinnitus Therapy System | Levo Medical Corporation | Aug 13, 2026 |
| K260277 | MIKRON TRAUMA BONE PLATE& SCREW SYSTEM | Mikron Makina San. ve Tic. Ltd. Sti. | Aug 13, 2026 |
| K260211 | Dashboard (P007000) | Hill-Rom, Inc. | Aug 13, 2026 |
| K254201 | Any-Cem | Mediclus Co., Ltd. | Aug 13, 2026 |
