Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

901 results for "Abbott Laboratories"
409–432 of 901
Search insights Median review: 61d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 29, 1991
ABBOTT IMX TOXO IGM POSITIVE CONTROL
K913106 · LGD
Abbott Laboratories
Microbiology · 140d
Cleared Nov 05, 1991
FLEXIFLO OVER-THE-GUIDEWIRE GAST KIT W/CR-BAR BUMP
K913786 · KNT
Abbott Laboratories
Gastroenterology & Urology · 74d
Cleared Oct 30, 1991
PANCRETEC PROVIDER ONE INFUSION SYSTEM, MODIFIED
K913720 · FRN
Abbott Laboratories
General Hospital · 90d
Cleared Oct 30, 1991
PANCRETEC I.V. MODEL 5500 INFUSER
K913719 · FRN
Abbott Laboratories
General Hospital · 90d
Cleared Oct 30, 1991
PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED
K913718 · FRN
Abbott Laboratories
General Hospital · 90d
Cleared Sep 23, 1991
FLEXIFLO OVER THE GUIDEWIRE JEJUNAL FEEDING TUBE
K912972 · FPD
Abbott Laboratories
Gastroenterology & Urology · 77d
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 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 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
Cleared Jan 31, 1991
FLEXIFLO STOMATE EXTENSION TUBE
K902623 · KNT
Abbott Laboratories
Gastroenterology & Urology · 231d
Cleared Jan 23, 1991
IMX FREE TRIIODOTHYRONINE
K905261 · CDP
Abbott Laboratories
Chemistry · 63d
Cleared Nov 27, 1990
FLEXIFLO STOMATE DECOMPRESSION TUBE
K903579 · KNT
Abbott Laboratories
Gastroenterology & Urology · 111d