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 |
|---|---|---|---|
| K262061 | Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEM | Stryker Spine | Jul 17, 2026 |
| K261984 | AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup | Assure Tech., LLC | Jul 17, 2026 |
| K261693 | Diode laser hair removal machine (QDTM-04) | Beijing Nubway S&T Co., Ltd. | Jul 17, 2026 |
| K261675 | CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D) | Shenzhen Chuanghong Zhilian Technology Co., Ltd. | Jul 17, 2026 |
| K261658 | LoFric Origo Pro Coudé | Wellspect AB | Jul 17, 2026 |
| K261614 | LED LCD Monitor (OEV-271H) | Lg Electronics.Inc | Jul 17, 2026 |
| K261475 | BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit | Biofire Defense, LLC | Jul 17, 2026 |
| K261046 | Dental Zirconia Blank & Coloring Liquid | Hunan Qinghao Puzhong Technology Co., Ltd. | Jul 17, 2026 |
| K260694 | ZEISS CLINIC 360 | Carl Zeiss Meditec, AG | Jul 17, 2026 |
| K254006 | Drivewire 35 Guidewire | Rapid Medical Ltd. | Jul 17, 2026 |
| K253963 | Cubresa BrainPET | Cubresa, Inc. | Jul 17, 2026 |
| K253694 | Natural Cycles | Natural Cycles Nordic AB | Jul 17, 2026 |
| K253011 | Catalyft PL Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | Jul 17, 2026 |
| K251952 | Virasight | Virasoft Corporation | Jul 17, 2026 |
| DEN250040 | SportSuite Vision Software | Stryker Endoscopy | Jul 17, 2026 |
| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB ) | TriMed, Inc. | Jul 16, 2026 |
| K261706 | Endomat Select (UP220) | KARL STORZ SE & CO. KG | Jul 16, 2026 |
| K261674 | Skin Air Cooling System (QALF-01) | Beijing Nubway S&T Co., Ltd. | Jul 16, 2026 |
| K261309 | Palisades™ Buttress Plate System | Bethesda Medical Devices, LLC | Jul 16, 2026 |
| K261271 | Cable-Ready® Cable Grip System | Pioneer Surgical Technology, Inc. | Jul 16, 2026 |
| K260021 | cobas® BV/CV | Roche Molecular Systems, Inc. | Jul 16, 2026 |
| K260002 | Socrates Aspiration System (Socrates 70 Aspiration Catheter) | Scientia Vascular, Inc. | Jul 16, 2026 |
| P250025 | TorEx Lung Perfusion System | Traferox Technologies, Inc. | Jul 15, 2026 |
| K262030 | Aventus Thrombectomy System | Inquis Medical | Jul 15, 2026 |
| K262006 | EnSite™ X EP System | Abbott Medical | Jul 15, 2026 |
| K261407 | XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422, XPRE434, XPRE451, XPRE455, XPRE457, XPRE448, XPRE335, XPRE350, XPRE420, XPRE436, XPRE339, XPRE445) | Dongguan Miqiang Technology Co., Ltd. | Jul 15, 2026 |
| K261353 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System | Kyocera Medical Technologies, Inc. | Jul 15, 2026 |
| K260851 | Better Diagnostics Dental Assist (BDDA) Version 1.0 | Better Diagnostics AI Corp. | Jul 15, 2026 |
| K260739 | Profoject™ Pen Needles (Model A; Model B) | CMT Health PTE., Ltd. | Jul 15, 2026 |
| K260338 | ThinkSono Guidance | ThinkSono GmbH | Jul 15, 2026 |
