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
162529–162552 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 01, 1981
ACRIDINE ORANGE STAIN
K812212 · IDC
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 27d
Cleared Sep 01, 1981
ANTITHROMBIN III SCREEN KIT
K812215 · JBQ
Pacific Hemostasis
Hematology · 27d
Cleared Sep 01, 1981
HELENA HBF QUIPLATE CONTROL
K812226 · KQI
Helena Laboratories
Hematology · 22d
Cleared Sep 01, 1981
GELMAN IG-FIX KIT
K812253 · CZP
Gelman Sciences, Inc.
Chemistry · 21d
Cleared Sep 01, 1981
AURAMINE O MYCROBACTERIAL STAIN SET
K812274 · KJK
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 19d
Cleared Sep 01, 1981
CELESTIN DILATOR
K812289 · KNQ
Inmed Corp.
Gastroenterology & Urology · 19d
Cleared Sep 01, 1981
GLUCOSE-HK SYSTEM PACK TEST
K812303 · CFR
Boehringer Mannheim Corp.
Chemistry · 14d
Cleared Sep 01, 1981
SANDARE URIC ACID PROCEDURE
K812313 · LFQ
Sandare Chemical Co., Inc.
Chemistry · 15d
Cleared Sep 01, 1981
CRITHIDNA ANTI-DNA TEST KIT
K812314 · DHN
Antibodies, Inc.
Immunology · 15d
Cleared Sep 01, 1981
LIPO-SEP CHOLESTEROL AUDIT SYSTEM
K812318
Isolab, Inc.
Chemistry · 15d
Cleared Sep 01, 1981
KAPPA & LAMBDA BENCE JONES CONTROLS
K812327 · CZQ
Kallestad Laboratories, Inc.
Immunology · 14d
Cleared Sep 01, 1981
ZETA-SERA D
K812329 · KIS
Amf Biological and Diagnostics Co.
Microbiology · 14d
Cleared Sep 01, 1981
B-NEOCEPT
K812334 · JHJ
Organon, Inc.
Chemistry · 14d
Cleared Sep 01, 1981
UREA NITROGEN (BUN)
K812341 · CDQ
Pointe Scientific, Inc.,
Chemistry · 14d
Cleared Sep 01, 1981
VENTREX DATA REDUCTION & QUAL. CONTR. SY
K812357 · JPK
Ventrex Laboratories, Inc.
Chemistry · 12d
Cleared Aug 31, 1981
NEOLOOPS
K810890 · DWS
Medical Marketing Systems
Cardiovascular · 151d
Cleared Aug 31, 1981
CARL ZEISS INN MYRINGOTOMY TUBE LINE
K811698 · ETD
James L. Geraci & Associates, Inc.
Ear, Nose, Throat · 76d
Cleared Aug 31, 1981
TRYPIN (125I) RIA KIT
K811805 · JNO
Bd Becton Dickinson Vacutainer...
Chemistry · 68d
Cleared Aug 31, 1981
S-610 SHUNT ADAPTOR SET
K811851 · KNR
Dravon Medical, Inc.
Gastroenterology & Urology · 61d
Cleared Aug 31, 1981
GAMBRO LUNDIA PLATE HIGH FLUX DIALYZER
K811944 · KDI
Gambro, Inc.
Gastroenterology & Urology · 55d
Cleared Aug 31, 1981
THE AMP 80/2 PEDIATRIC CYCLER SYSTEM
K811986 · FKX
American Medical Products, Inc.
Gastroenterology & Urology · 49d
Cleared Aug 31, 1981
BO MED BIA
K811999 · DSB
Bomed Medical Mfr., Ltd.
Cardiovascular · 51d
Cleared Aug 31, 1981
K-MED SILICONE SUMP DRAIN W/ SHEATH
K812025
K-Med, Inc.
General & Plastic Surgery · 42d
Cleared Aug 31, 1981
K-MED SILICONE SUMP DRAIN
K812026
K-Med, Inc.
General & Plastic Surgery · 42d