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

70993–71016 of 174,955

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

Cleared Jul 18, 2003

PROVIDENCE MOLDING HELMET

Northeast Orthotics and Prothetics, Inc.

Neurology · 137d

Cleared Jul 18, 2003

PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT

Anesthesiology · 106d

Cleared Jul 18, 2003

PRIMA III TOTALSENSE TORSO COIL

Usa Instruments, Inc.

Radiology · 79d

Cleared Jul 18, 2003

HYDROGENICS 2.0 60 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS

Ocular Sciences, Inc.

Ophthalmic · 70d

Cleared Jul 18, 2003

ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX

Koven Technology, Inc.

Radiology · 65d

Cleared Jul 18, 2003

BRAIN COIL, MODEL 9900GE-64

Clinical MR Solutions, LLC

Radiology · 63d

Cleared Jul 18, 2003

STEREOTACTIC BODY FRAME, MODEL COD. 70-1A

3D Line USA, Inc.

Radiology · 52d

Cleared Jul 18, 2003

MODIFICATION TO COOK ZILVER BILIARY STENT

Gastroenterology & Urology · 35d

Cleared Jul 18, 2003

MODIFICATION TO WBR, MODEL HR

U.C.G. Technologies , Ltd.

Radiology · 31d

Cleared Jul 18, 2003

Radiology · 29d

Cleared Jul 18, 2003

APEEL CS CATHETER DELIVERY SYSTEM

St Jude Medical

Cardiovascular · 28d

Cleared Jul 18, 2003

PHILIPS VIEWFORUM 2003

Philips Medical Systems

Radiology · 10d

Cleared Jul 18, 2003

ACUSON CV70 CARDIOVASCULAR SYSTEM

Siemens Medical Solutions USA, Inc.

Radiology · 9d

Cleared Jul 17, 2003

ELECTROMEDICARIN 900

Electromedicarin, S.A.

Physical Medicine · 519d

Cleared Jul 17, 2003

COMPPAC VENTILATOR MODELS 200 & PS11 POWER SUPPLY/CHARGER

Anesthesiology · 407d

Cleared Jul 17, 2003

MX 300 OXYGEN MONITOR

Teledyne Analytical Instruments

Anesthesiology · 212d

Cleared Jul 17, 2003

RX300 OXYGEN ANALYZER

Teledyne Analytical Instruments

Anesthesiology · 206d

Cleared Jul 17, 2003

SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEM

Spinal Concepts, Inc.

Orthopedic · 189d

Cleared Jul 17, 2003

UNIT, CAUTERY, TEHRMAL,BATTERY-POWERED

Walsh Medical Devices, Inc.

General & Plastic Surgery · 182d

Cleared Jul 17, 2003

POLYGRAFT BONE GRAFT SUBSTITUTE

Osteobiologics, Inc.

Orthopedic · 170d

Cleared Jul 17, 2003

LUMENIS FAMILY OF IPL SYSTEMS AND COMBINATION IPL/ND:YAG SYSTEMS

General & Plastic Surgery · 164d

Cleared Jul 17, 2003

CEFAR REHAB 2 AND REHAB 2 PRO

Cefar Medical AB

Physical Medicine · 161d

Cleared Jul 17, 2003

Photo Therapeutics Limited

General & Plastic Surgery · 157d

Cleared Jul 17, 2003

Andi Electromedical Aps

Physical Medicine · 134d