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
136513–136536 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 06, 1988
CRANK FRAME RETRACTOR
K881160 · GZT
T. Korossurgical Instruments Corp.
Neurology · 19d
Cleared Apr 06, 1988
NOVA GEL(TM) SM/RNP
K881181 · LLL
Inova Diagnostics, Inc.
Immunology · 35d
Cleared Apr 06, 1988
MTI WOLFF SYSTEM
K881353 · LEJ
Health Systems Intl., Inc.
General & Plastic Surgery · 7d
Cleared Apr 05, 1988
GLYCO-PROBE GSP
K873428 · LCP
Isolab, Inc.
Chemistry · 224d
Cleared Apr 05, 1988
FIRST RESPONSE 5 MINUTE PREGNANCY TEST
K874823 · LCX
Tambrands, Inc.
Chemistry · 133d
Cleared Apr 05, 1988
MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE
K875079 · CKA
Miles Laboratories, Inc.
Chemistry · 118d
Cleared Apr 05, 1988
EMIT 700 CANNABINOID 100 NG CALIBRATOR & CONTROL
K875135 · DLJ
Syva Co.
Toxicology · 113d
Cleared Apr 05, 1988
ABBOTT IMX HTSH
K880086 · JLW
Abbott Laboratories
Chemistry · 84d
Cleared Apr 05, 1988
ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHAT
K880177 · CIO
Tech-Co, Inc.
Chemistry · 81d
Cleared Apr 05, 1988
INTRAFORM TOTAL HIP SYSTEM
K880390 · JDI
Orthomet, Inc.
Orthopedic · 67d
Cleared Apr 05, 1988
HUMAN CHORIONIC GONADOTROPIN VISUAL TEST KIT
K880410 · JHI
Disease Detection International, Inc.
Chemistry · 64d
Cleared Apr 05, 1988
LYPHOCHEK URINE TOXICOLOGY CONTROL - LOW
K880445 · DIF
Bio-Rad
Toxicology · 63d
Cleared Apr 05, 1988
DRUG MIXTURE CONTROL IN URINE
K880512 · DIF
Eastern Laboratories, Ltd.
Toxicology · 56d
Cleared Apr 05, 1988
PROFECT SURGEONS' GLOVES
K880535 · KGO
Network Trading Corp.
General Hospital · 56d
Cleared Apr 05, 1988
MODIFIED VENTRESCREEN BETA HCG ENZYME IMMUNOASSAY
K880678 · DHA
Ventrex Laboratories, Inc.
Chemistry · 46d
Cleared Apr 05, 1988
ABBOTT A-GENT NEONATAL BILIRUBIN REAGENT
K880743 · CIG
Abbott Laboratories
Chemistry · 41d
Cleared Apr 05, 1988
LDH-L REAGENT SET
K880842 · CFJ
Tech-Neal Scientific, Inc.
Chemistry · 39d
Cleared Apr 05, 1988
CREATININE REAGENT SET (KINETIC)
K880843 · CGX
Tech-Neal Scientific, Inc.
Chemistry · 39d
Cleared Apr 05, 1988
ALBUMIN REAGENT SET
K880844 · CIX
Tech-Neal Scientific, Inc.
Chemistry · 39d
Cleared Apr 05, 1988
CALCIUM REAGENT SET
K880845 · CIC
Tech-Neal Scientific, Inc.
Chemistry · 39d
Cleared Apr 05, 1988
SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER
K880949 · CJY
Advanced Biomedical Methods, Inc.
Chemistry · 29d
Cleared Apr 05, 1988
DISPOSABLE STERILE LATEX SURGICAL GLOVES
K881069 · KGO
Komin Trading Co.
General Hospital · 22d
Cleared Apr 05, 1988
UNIVERSAL STERNUM SPREADER AND I.M.A. RETRACTOR
K881156 · GAD
T. Korossurgical Instruments Corp.
General & Plastic Surgery · 18d
Cleared Apr 05, 1988
I.M.A. RETRACTOR
K881159 · GAD
T. Korossurgical Instruments Corp.
General & Plastic Surgery · 18d