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
149857–149880 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 18, 1985
TDX TOTAL ESTRIOL
K844511 · CGI
Abbott Laboratories
Chemistry · 59d
Cleared Jan 18, 1985
MODEL 1020 NA+/K+(SODIUM/POTASSIUM)ANALYZER MULTI
K844559 · JGS
Thermo Orion
Chemistry · 58d
Cleared Jan 18, 1985
PRE-KLENE ENAMEL CLEANER
K844572 · EFT
Medical Products Laboratories, Inc.
Dental · 56d
Cleared Jan 18, 1985
AVL MODEL 982 ELECTROLYTE ANALYZER
K844587 · JGS
Avl Scientific Corp.
Chemistry · 56d
Cleared Jan 18, 1985
ASAHI NEW PAN-SERIES HEMOFILTERS
K844663 · KDI
Asahi Medical Co., Ltd.
Gastroenterology & Urology · 49d
Cleared Jan 18, 1985
PEDIATRIC SIZED HEMOCATH CATHETER
K844692 · FIQ
Quinton, Inc.
Gastroenterology & Urology · 46d
Cleared Jan 18, 1985
SURGICAL SCALPEL BLADES & DISPOSABLES
K844759 · GES
Cross Country Paper Products Corp.
General & Plastic Surgery · 42d
Cleared Jan 18, 1985
NURSES & SURGEONS CAPS, ISOLATION GOWNS-FIRE RETAR
K844786 · FYC
Durawear
General Hospital · 39d
Cleared Jan 18, 1985
CLINIFACTS 10 DATA MANAGEMENT SYSTEM
K844907 · JQP
Miles Laboratories, Inc.
Chemistry · 32d
Cleared Jan 18, 1985
ARRHYTHMIA CENTRAL-OGP-7201
K844911 · DRT
Nihon Kohden America, Inc.
Cardiovascular · 31d
Cleared Jan 18, 1985
UNITED SKIN BARRIERS
K844938 · EXB
Pfizer, Inc.
Gastroenterology & Urology · 29d
Cleared Jan 18, 1985
EMIT IMIPRAMINE/DESIPRAMINE CONTROL
K844945 · DIF
Syva Co.
Toxicology · 29d
Cleared Jan 18, 1985
EMIT AMITRIPTYLINE/NORTRIPTYLINE CONTROL
K844946 · DIF
Syva Co.
Toxicology · 29d
Cleared Jan 18, 1985
EMIT QST ACETAMINOPHEN ASSAY
K844962 · LDP
Syva Co.
Toxicology · 25d
Cleared Jan 18, 1985
VAS-CATH CONTINOUS EPIDURAL ANESTH. CATH/KIT/TRAY
K844982 · CAZ
Vas-Cath of Canada , Ltd.
Anesthesiology · 23d
Cleared Jan 18, 1985
ROCHE REAGENTS REAGENT FOR URIC ACID
K844986 · CDO
Roche Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Jan 18, 1985
ROCHE REAGENTS REAGENT FOR CO2
K844987 · KHS
Roche Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Jan 18, 1985
GLUCOSE(HEXOKINASE) REAGENT SET
K844998 · CFR
Sterling Biochemical, Inc.
Chemistry · 23d
Cleared Jan 18, 1985
BAKER CKMB REAGENT SET
K845024 · JHY
Hybritech, Inc.
Chemistry · 22d
Cleared Jan 18, 1985
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES
K845027 · CHI
Eastman Kodak Company
Chemistry · 22d
Cleared Jan 18, 1985
DU PONT TOBRAMYCIN ASSAY CALIBRATOR
K850057 · DLJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 10d
Cleared Jan 18, 1985
DU PONT TOBRAMYCIN ASSAY REAGENTS
K850058 · LCR
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 10d
Cleared Jan 18, 1985
DU PONT GENTAMICIN ASSAY CALIBRATOR
K850059 · DLJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 10d
Cleared Jan 18, 1985
DU PONT GENTAMICIN ASSAY REAGENTS
K850060 · LCD
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 10d