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
132625–132648 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 09, 1989
IMX B2-MICROGLOBULIN
K890421 · JZG
Abbott Laboratories
Immunology · 42d
Cleared Mar 09, 1989
ALASTIGARD
K890529 · EJF
Unitek Corp.
Dental · 35d
Cleared Mar 09, 1989
WELLSHIRE BASELINK
K890558 · DXH
American Executive Technology
Cardiovascular · 31d
Cleared Mar 09, 1989
ULTIMA LITE
K890568 · EJT
Deringer-Ney, Inc.
Dental · 31d
Cleared Mar 09, 1989
NEYORO 65CF
K890569 · EJT
Deringer-Ney, Inc.
Dental · 31d
Cleared Mar 09, 1989
KENLOR HUMAN SPINAL FLUID CONTROL LIQUID
K890576 · JJY
Kenlor Industries, Inc.
Chemistry · 31d
Cleared Mar 09, 1989
KENLOR LIQUID URINE CONTROL
K890577 · JJW
Kenlor Industries, Inc.
Chemistry · 31d
Cleared Mar 09, 1989
BTE HEARING AID OTICON MODEL: E42P
K890704 · ESD
Oticon Corp.
Ear, Nose, Throat · 27d
Cleared Mar 09, 1989
MEDIMOD(TM), MODEL 8900
K890705 · GZJ
Medical Devices, Inc.
Neurology · 27d
Cleared Mar 09, 1989
ABUSCREEN FP FOR BARBITURATES
K890884 · DIS
Roche Diagnostic Systems, Inc.
Toxicology · 16d
Cleared Mar 09, 1989
HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL:
K890957 · DIF
Hycor Biomedical, Inc.
Toxicology · 10d
Cleared Mar 08, 1989
DELFIA HLH SPEC KIT
K883814 · CEP
Pharmacia, Inc.
Chemistry · 181d
Cleared Mar 08, 1989
PREEMICARE SERIES 4000 PHOTOTHERAPY LAMP
K884133 · LBI
Preemicare Corp.
General Hospital · 159d
Cleared Mar 08, 1989
C&T PREGNANCY TEST KIT
K884489 · LCX
Healthcheck Corp.
Chemistry · 133d
Cleared Mar 08, 1989
SERALYZER DIGOXIN ASSAY/TEST MOD/CALIB/CONTR/AMES
K884528 · KXT
Heraeus Kulzer, Inc.
Chemistry · 131d
Cleared Mar 08, 1989
ASPARTATE AMINOTRANSFERASE (AST)
K884724 · CIT
Catachem, Inc.
Chemistry · 118d
Cleared Mar 08, 1989
DELFIA SHBG KIT
K884809 · CDZ
Pharmacia, Inc.
Chemistry · 111d
Cleared Mar 08, 1989
MODEL 1000 ELECTRONIC CLINICAL THERMOMETER
K885187 · FLL
Mon-A-Therm, Inc.
General Hospital · 84d
Cleared Mar 08, 1989
FLIPSCREEN (TM) TOTAL E IMMUNOASSAY
K885307 · DGC
Alerchek, Inc.
Immunology · 71d
Cleared Mar 08, 1989
VAC-RITE
K885334 · GCX
Bd Becton Dickinson Vacutainer...
General Hospital · 70d
Cleared Mar 08, 1989
ADMS BIOPSY NEEDLE
K890203 · FCG
Advanced Diagnostic Medical Systems,...
Gastroenterology & Urology · 50d
Cleared Mar 08, 1989
ALKALINE PHOSPHATASE ISOENZYME REAGENTS
K890269 · CIN
Beckman Instruments, Inc.
Chemistry · 49d
Cleared Mar 08, 1989
TOTAL PROTEIN REAGENT
K890317 · CEK
Medical Analysis Systems, Inc.
Chemistry · 44d
Cleared Mar 08, 1989
BIOPSY NEEDLE GUIDE ATTACHMENT
K890327 · FCG
Elscint, Inc.
Gastroenterology & Urology · 44d