FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×

174,955 results

70393–70416 of 174,955

Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery

Cleared Sep 17, 2003

SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES

Orthopedic · 56d

Cleared Sep 17, 2003

THE LIFECORE STAGE-1 ANGLED ABUTMENT SYSTEM

Lifecore Biomedical, Inc.

Cleared Sep 17, 2003

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFOXITIN-GRAM NEGATIVE

Becton, Dickinson & CO

Microbiology · 28d

Cleared Sep 17, 2003

TSRH SPINAL SYSTEM

Medtronic Sofamor Danek, Inc.

Orthopedic · 27d

Cleared Sep 17, 2003

UNITY NETWORK PATIENT DATA SERVER

Ge Medical Systems Information...

Cardiovascular · 27d

Cleared Sep 17, 2003

RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30629

Rubicor Medical, Inc.

General & Plastic Surgery · 27d

Cleared Sep 17, 2003

LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743

Hematology · 23d

Cleared Sep 17, 2003

APAX PACS SYSTEM

Radiology · 12d

Cleared Sep 16, 2003

AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 10060060

Idev Technologies, Inc.

Cardiovascular · 209d

Cleared Sep 16, 2003

PENTACAM SCHEIMPFLUG CAMERA

Oculus Optikgerate GmbH

Ophthalmic · 193d

Cleared Sep 16, 2003

CANDELA SMOOTHBEAM LASER SYSTEM

General & Plastic Surgery · 183d

Cleared Sep 16, 2003

Soft-Core Texas, Inc.

Physical Medicine · 126d

Cleared Sep 16, 2003

General & Plastic Surgery · 118d

Cleared Sep 16, 2003

OSSEOTITE IOL IMPLANTS AND OSSEOTITE CERTAIN IOL IMPLANTS

Implant Innovations, Inc.

Cleared Sep 16, 2003

MEDLINE REUSABLE SURGICAL GOWNS (100X)

Medline Industries, Inc.

General Hospital · 85d

Cleared Sep 16, 2003

PERIPATCH SHEET, MODELS 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16

Pm Devices, Inc.

Cardiovascular · 84d

Cleared Sep 16, 2003

Shofu Dental Corp.

Cleared Sep 16, 2003

HYDROCISION ARTHROJET SYSTEM WITH CAUTERY, TURBOBURR AND CURETTE, MODELS...

Hydrocision, Inc.

Orthopedic · 32d

Cleared Sep 16, 2003

MODIFICATION TO CONTOUR SE MICROSPHERES

Boston Scientific Corp

Neurology · 29d

Cleared Sep 16, 2003

SHORT INTRODUCER SHEATH

Cardiovascular · 27d

Cleared Sep 16, 2003

ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300

Asahi Intecc Co., Ltd.

Cardiovascular · 22d

Cleared Sep 16, 2003

BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000

Belmont Instrument Corp.

General Hospital · 18d

Cleared Sep 16, 2003

BEDSIDE MONITOR, MODEL OPV-1500

Nihon Kohden America, Inc.

Cardiovascular · 11d

Cleared Sep 15, 2003

LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDMA, ACCUSIGN STIK...

Princeton BioMeditech Corp.

Toxicology · 301d