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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
135913–135936 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 06, 1988
SM ANTIBODY TEST KIT
K880254 · LKP
Lipogen, Inc.
Immunology · 77d
Cleared Apr 06, 1988
POLE, INTRAVENOUS
K880537 · FOX
Ferguson Medical
General Hospital · 57d
Cleared Apr 06, 1988
TECA/MEDELEC MISTRAL
K880593 · GWE
Teca, Inc.
Neurology · 55d
Cleared Apr 06, 1988
ENDOSCOPIC ELASTIC BAND LIGATOR
K880648 · FHN
Superior Healthcare Group, Inc.
Gastroenterology & Urology · 49d
Cleared Apr 06, 1988
ULTIMA XS (TENS)
K880751 · GZJ
American Imex
Neurology · 42d
Cleared Apr 06, 1988
KOI(TM) INSTRUMENT TRAYS
K881095 · LRP
CooperVision, Inc.
General & Plastic Surgery · 22d
Cleared Apr 06, 1988
K ORTHOPEDIC TABLE
K881101 · JEB
Instrumentation Specialties, Inc.
General & Plastic Surgery · 22d
Cleared Apr 06, 1988
QM300 ALBUMIN ANTIBODY PACK
K881126 · DCF
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 21d
Cleared Apr 06, 1988
MICROSCRAPE
K881151 · LXK
Ortho Pharmaceutical Corp.
General & Plastic Surgery · 20d
Cleared Apr 06, 1988
STERNUM SPREADER AND MITRAL VALVE RETRACTOR
K881157 · GAD
T. Korossurgical Instruments Corp.
General & Plastic Surgery · 19d
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