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
73345–73368 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 08, 2002
PRECLUDE MVP DURA SUBSTITUTE
K021477 · GXQ
W.L. Gore & Associates, Inc.
Neurology · 184d
Cleared Nov 08, 2002
SUNPEX TECHNOLOGIES MODEL SE 01
K021925 · INI
Sunpex Technology Co., Ltd.
Physical Medicine · 150d
Cleared Nov 08, 2002
STRYKER POWERED WHEELED STRETCHER
K022309 · INK
Stryker Corp.
Physical Medicine · 115d
Cleared Nov 08, 2002
NITRI GRIP POWDERED NITRILE EXAMINATION GLOVES
K022572 · LZA
Ar Alliance Healthcare Sdn. Bhd.
General Hospital · 98d
Cleared Nov 08, 2002
COLUMBUS TOTAL KNEE SYSTEM (CR)
K022672 · JWH
Aesculap, Inc.
Orthopedic · 88d
Cleared Nov 08, 2002
PRIMAGARD SURGICAL EQUIPMENT DRAPES
K022868 · KKX
Primeline Medical Products, Inc.
General Hospital · 71d
Cleared Nov 08, 2002
PRIMAGARD SURGICAL GOWNS
K023117 · KKX
Primeline Medical Products, Inc.
General Hospital · 58d
Cleared Nov 08, 2002
SPERM CRYOPROTEC
K023206 · MQL
Nidacon International AB
Obstetrics & Gynecology · 44d
Cleared Nov 08, 2002
PRIMAGARD SURGICAL GOWNS
K023266 · FYA
Primeline Medical Products, Inc.
General Hospital · 39d
Cleared Nov 08, 2002
HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY
K023398 · KGI
Hologic, Inc.
Radiology · 30d
Cleared Nov 08, 2002
HA X-SERIES BI-METRIC HIP FEMORAL COMPONENTS
K023409 · LPH
Biomet, Inc.
Orthopedic · 29d
Cleared Nov 08, 2002
MODIFICATION TO NEOTHERMIA'S EN-BLOC BIOPSY SYSTEM
K023413 · GEI
Neothermia Corp.
General & Plastic Surgery · 28d
Cleared Nov 08, 2002
MODIFICATION TO VKS KNEE SYSTEM
K023416 · JWH
Plus Orthopedics
Orthopedic · 28d
Cleared Nov 08, 2002
MODIFICATION TO GELBFISH VASCULAR DILATORS
K023507 · DRE
Vascumetrix, LLC
Cardiovascular · 21d
Cleared Nov 08, 2002
ECAT LSO PET/CT 16
K023518 · KPS
Cti Pet Systems, Inc.
Radiology · 18d
Cleared Nov 08, 2002
POWDERED NATURAL AND/OR COLORED LATEX EXAM GLOVES
K023590 · LYY
Yty Industry (Manjung) Sdn Bhd
General Hospital · 14d
Cleared Nov 08, 2002
MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL
K023596 · MOS
Medrad, Inc.
Radiology · 11d
Cleared Nov 07, 2002
OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER
K014218 · DQA
Dolphin Medical, Inc.
Anesthesiology · 321d
Cleared Nov 07, 2002
ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE
K020003 · DRX
Bio Protech, Inc.
Cardiovascular · 309d
Cleared Nov 07, 2002
FUNDUS AUTOIMAGER
K020888 · HKI
Visual Pathways, Inc.
Ophthalmic · 234d
Cleared Nov 07, 2002
ARTHREX FIBERWIRE IN USP SIZES
K021434 · GAT
Arthrex, Inc.
General & Plastic Surgery · 185d
Cleared Nov 07, 2002
PISTON SYRINGE & HYPODERMIC NEEDLE
K022159 · FMF
International Medsurg Connection
General Hospital · 128d
Cleared Nov 07, 2002
TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH
K022655 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 90d
Cleared Nov 07, 2002
PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL
K022675 · EBF
Prime Dental Manufacturing, Inc.
Dental · 87d