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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

1,299 results for "abbott"
1105–1128 of 1,299
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 14, 1983
ABBOTT IGE EIA
K832360 · DGC
Abbott Laboratories
Chemistry · 88d
Cleared Oct 05, 1983
CHLAMYDIAZYME, ENZYME IMMUNOASSAY DETEC
K831962 · LJC
Abbott Laboratories
Chemistry · 110d
Cleared Sep 29, 1983
ABBOTT GLOBE HOLDER
K832911 · HJO
Miami Eye Technology, Inc.
Ophthalmic · 31d
Cleared Sep 29, 1983
A-GENT GLYCOSYLATED HEMOGLOBIN
K832775 · LCP
Abbott Laboratories
Chemistry · 44d
Cleared Sep 26, 1983
CELL-DYN 900 HEMATOLOGY ANALYZER
K832643 · GKL
Abbott Diagnostics
Hematology · 53d
Cleared Sep 26, 1983
QUANTUM II YEAST IDENT. SYSTEM
K832406 · JXC
Abbott Laboratories
Microbiology · 67d
Cleared Sep 12, 1983
A-GENT CARBAMAZEPINE
K832631 · KLT
Abbott Laboratories
Toxicology · 39d
Cleared Sep 12, 1983
A-GENT PHENOBARBITAL
K832457 · DLZ
Abbott Laboratories
Toxicology · 48d
Cleared Sep 12, 1983
LIFECARE MICRO PUMP
K832289 · FRN
Abbott Laboratories
General Hospital · 61d
Cleared Sep 01, 1983
A-GENT PHERYTOIN
K832419 · DIP
Abbott Laboratories
Toxicology · 41d
Cleared Aug 31, 1983
VESSEL DILATOR
K832595 · DWP
Abbott Laboratories
Cardiovascular · 29d
Cleared Aug 24, 1983
SPECTROPHOTOMETER #390
K832206 · JJQ
Abbott Diagnostics
Toxicology · 48d
Cleared Aug 12, 1983
VENIPUNCTURE VALVE
K832123 · FPA
Abbott Laboratories
General Hospital · 43d
Cleared Aug 12, 1983
PROMINJET PUMP
K832120 · FRN
Abbott Laboratories
General Hospital · 43d
Cleared Jul 28, 1983
PRO QUANTUM
K831249 · JQW
Abbott Laboratories
Chemistry · 101d
Cleared Jul 18, 1983
CELL-DYN 300 HEMATOLOGY ANALYZER
K832038 · GKL
Abbott Diagnostics
Hematology · 24d
Cleared Jul 18, 1983
CELL-DYN 400 HEMOTOLOGY ANALYZER
K831368 · GKL
Abbott Diagnostics
Hematology · 83d
Cleared Jun 03, 1983
Y-TYPE BACKCHECK MICROBORE EXTEN. SET
K831203 · FRN
Abbott Laboratories
General Hospital · 51d
Cleared Jun 02, 1983
MILLER-ABBOTT TUBE
K830998 · KNT
Medovations, Inc.
Gastroenterology & Urology · 65d
Cleared May 05, 1983
PREALBUMIN ENZYME IMMUNOASSAY
K821135 · JZJ
Abbott Laboratories
Hematology · 380d
Cleared Apr 14, 1983
PCA PUMP
K830452 · FRN
Abbott Laboratories
General Hospital · 58d
Cleared Apr 12, 1983
TDX T-UPTAKE
K830912 · KHQ
Abbott Laboratories
Chemistry · 22d
Cleared Apr 08, 1983
QUANTUM II BACTERIAL IDENT. SYSTEM
K830698 · JSS
Abbott Laboratories
Microbiology · 32d
Cleared Apr 06, 1983
TDX THYROXINE
K830683 · KLI
Abbott Laboratories
Chemistry · 33d