FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
123505–123528 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 17, 1991
MAGNETIC RESONANCE THERAPY DEVICE
K903675 · ILX
Mrt, Inc.
Physical Medicine · 157d
Cleared Jan 17, 1991
DE-TOX TUBES A AND DE-TOX TUBES B
K904326 · DPA
Dyna-Tek Industries
Toxicology · 119d
Cleared Jan 17, 1991
DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176
K904468 · CIG
Amresco, Inc.
Chemistry · 108d
Cleared Jan 17, 1991
THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM
K904816 · CDX
Bd Becton Dickinson Vacutainer...
Toxicology · 85d
Cleared Jan 17, 1991
SHBG IRMA KIT
K905247 · CDZ
Ventrex Laboratories, Inc.
Chemistry · 57d
Cleared Jan 17, 1991
WILL-CERAM BRUSHES, SUPER BRUSH KIT
K905328 · EIH
Ivoclar North America, Inc.
Dental · 50d
Cleared Jan 17, 1991
AUTO SUTURE MODIFIED SURGITIE ENDO. LIGATING LOOP
K905379 · GAR
United States Surgical, A Division of...
General & Plastic Surgery · 48d
Cleared Jan 17, 1991
CREATINE KINASE UV REAGENT SET
K905588 · JHW
Biochemical Trade, Inc.
Chemistry · 35d
Cleared Jan 17, 1991
ECLIPSE ICA TRIGLYCERIDES
K905601 · CDT
Biotope, Inc.
Chemistry · 35d
Cleared Jan 17, 1991
CEDIA PHENYTOIN ASSAY
K905689 · DIP
Microgenics Corp.
Toxicology · 29d
Cleared Jan 17, 1991
ECLIPSE ICA DIGOXIN
K905719 · DPO
Biotope, Inc.
Toxicology · 27d
Cleared Jan 17, 1991
ABUSCREEN ONLINE COCAINE METABOLITE CALIBRATORS
K910086 · DLJ
Roche Diagnostic Systems, Inc.
Toxicology · 9d
Cleared Jan 16, 1991
DATASCOPE ARTERIAL CANNULA W/ACCESS PORT
K902674 · DQR
Datascope Corp.
Cardiovascular · 212d
Cleared Jan 16, 1991
CYTOASPIRATOR
K902910 · FCK
H & B Medical Technology, Inc.
Gastroenterology & Urology · 198d
Cleared Jan 16, 1991
IPG-II MODULE
K903700 · DSB
Life Sciences Manufacturing, Inc.
Cardiovascular · 154d
Cleared Jan 16, 1991
RHEOLOGIC I
K903711 · IPF
Advanced Rehabilitative Technology, Inc.
Physical Medicine · 155d
Cleared Jan 16, 1991
NEUROMED TS8 TEST STIMULATOR
K903814 · GZB
Neuromed, Inc.
Neurology · 149d
Cleared Jan 16, 1991
SPEEDWRAP, DYNAWRAP, DYNAPLAST TAPE
K903823 · KGX
Smith and Nephew Donjoy, Inc.
General & Plastic Surgery · 149d
Cleared Jan 16, 1991
BIFURCATED GORE TEX STRETCH VASCULAR GRAFT
K904282 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 120d
Cleared Jan 16, 1991
STEALTH DILATION CATHETER SYSTEM/MODIFICATION
K904287 · DYG
Target Therapeutics
Cardiovascular · 124d
Cleared Jan 16, 1991
F.T.I. MEDICAL LIGHT GUIDE
K904378 · EQH
Fiberoptics Technology, Inc.
Ear, Nose, Throat · 114d
Cleared Jan 16, 1991
ORION LIFE SYSTEMS REPLACEMENT GASTROSTOMY TUBE
K904801 · KGC
Orion Life Systems, Inc.
Gastroenterology & Urology · 84d
Cleared Jan 16, 1991
AUTOWAND(TM) 7XXX SERIES, MODIFICATION
K904888 · CAC
Boehringer Laboratories
Anesthesiology · 82d
Cleared Jan 16, 1991
CONDOR DIGITAL INFLATION SYRINGE
K904954 · MAV
Professional Medical Services
Cardiovascular · 72d