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"
769–792 of 1,299
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 23, 1991
FLEXIFLO OVER THE GUIDEWIRE JEJUNAL FEEDING TUBE
K912972 · FPD
Abbott Laboratories
Gastroenterology & Urology · 77d
Cleared Sep 19, 1991
ABBOTT QUICKSTART TIBC PRETREATMENT KIT, 5A29-01
K913922 · JMO
Em Diagnostic Systems, Inc.
Chemistry · 16d
Cleared Sep 19, 1991
ABBOTT QUICKSTART ALANINE AMINOTRANSFER
K913846 · CKA
Em Diagnostic Systems, Inc.
Chemistry · 22d
Cleared Sep 18, 1991
ABBOTT QUICKSTART CREATININE TEST(CREA) ITEM# 5A28
K913707 · CGX
Em Diagnostic Systems, Inc.
Chemistry · 30d
Cleared Sep 11, 1991
ABBOTT QUICKSTART BICARBONATE TEST CO2 ITEM# 5A22
K912806 · KHS
Em Diagnostic Systems, Inc.
Chemistry · 78d
Cleared Sep 11, 1991
IMX SELECT ANALYZER
K912368 · JJQ
Abbott Laboratories
Chemistry · 105d
Cleared Aug 26, 1991
LIFECARE 4100 PCA INFUSER PLUS II
K912928 · FRN
Abbott Laboratories
General Hospital · 82d
Cleared Aug 16, 1991
TDX(R)/TDXFLX(TM) & ADX(R) PROPOXPHENE ASSAYS
K912365 · JXN
Abbott Laboratories
Toxicology · 79d
Cleared Aug 12, 1991
ABBOTT QUICKSTART PHOSPHORUS(PHOS) ITEM #5A14
K912809 · CEO
Em Diagnostic Systems, Inc.
Chemistry · 48d
Cleared Aug 07, 1991
FLEXIFLO ENTERAL FEEDING TUBE
K910382 · KNT
Abbott Laboratories
Gastroenterology & Urology · 190d
Cleared Aug 02, 1991
MODIFIED LIFECARE MODEL 175 INFUSER
K912092 · FRN
Abbott Laboratories
General Hospital · 81d
Cleared Aug 02, 1991
MODIFIED PANCRETEC PROVIDER ONE INFUSION SYSTEM
K911964 · FRN
Abbott Laboratories
General Hospital · 92d
Cleared Jul 30, 1991
ABBOTT QUICKSTART TOTAL PROTEIN TEST ITEM# 5A13
K912810 · CEK
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Jul 30, 1991
ABBOTT QUICK START GLUCOSE (GLUE) ITEM# 5A15
K912808 · CFR
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Jul 26, 1991
ABBOTT QUICKSTART GAMMA-GLUTAMYTRANSFERASE TEST
K913024 · JQB
Em Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Jul 01, 1991
IMX TOTAL B-HCG
K912535 · JHI
Abbott Laboratories
Chemistry · 24d
Cleared Jul 01, 1991
IMX HCG
K912534 · JHI
Abbott Laboratories
Chemistry · 24d
Cleared May 28, 1991
ABBOTT LIFECARE 5000 PUMP
K911401 · FRN
Abbott Laboratories
General Hospital · 60d
Cleared May 23, 1991
ABBOTT LIFECARE 5000 PUMP MODIFIED
K910919 · FRN
Abbott Laboratories
General Hospital · 79d
Cleared Apr 16, 1991
INPERSOL CAPD BIOCAP ADMINISTRATION SET
K911094 · KDI
Abbott Laboratories
Gastroenterology & Urology · 34d
Cleared Apr 16, 1991
NUTRIMIX(R) MACRO(TM) TPN COMPOUNDER/MODIFICATION
K910213 · LHI
Abbott Laboratories
General Hospital · 96d
Cleared Mar 19, 1991
FLEXIFLO SACKS-VINE GASTROSTOMY KITS
K910332 · KNT
Abbott Laboratories
Gastroenterology & Urology · 53d
Cleared Feb 26, 1991
ABBOTT TOXO-M EIA HIGH POSITIVE CONTROL
K910416 · LGD
Abbott Laboratories
Microbiology · 27d
Cleared Feb 07, 1991
ABBOTT VISION(TM) GLYCATED HB
K904027 · LCP
Abbott Laboratories
Hematology · 161d