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

1,305 results for "Abbott"
793–816 of 1,305
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Nov 20, 1990
LABELING SUBMITTAL, ADX TM CANNABINOIDS-GS
K904541 · LDJ
Abbott Laboratories
Toxicology · 47d
Cleared Nov 19, 1990
FLEXIFLO (R) VERSA-PEG (TM) GASTROSTOMY KIT
K903325 · KNT
Abbott Laboratories
Gastroenterology & Urology · 117d
Cleared Oct 29, 1990
'TDXFLX ANALYZER
K904226 · LCQ
Abbott Laboratories
Chemistry · 46d
Cleared Oct 12, 1990
TDX FREE T3 CALCULATION
K903433 · CDP
Abbott Laboratories
Chemistry · 73d
Cleared Sep 25, 1990
ABBOTT TESTPACK PLUS TM HCG-COMBO
K903219 · JHI
Abbott Laboratories
Chemistry · 64d
Cleared Sep 19, 1990
AMBULATORY INFUSER AND ASSOC. FLOW CONTROLLING SET
K902432 · FRN
Abbott Laboratories
General Hospital · 111d
Cleared Sep 10, 1990
IMX FREE T4 CALCULATION
K903384 · CEC
Abbott Laboratories
Chemistry · 45d
Cleared Sep 10, 1990
TDX FREE T4 CALCULATION
K903383 · CEC
Abbott Laboratories
Chemistry · 45d
Cleared Sep 10, 1990
ABBOTT VISION LYTE (TM) SODIUM
K903188 · JGS
Abbott Laboratories
Chemistry · 53d
Cleared Sep 07, 1990
IMX FREE T3 CALCULATION
K903432 · CDP
Abbott Laboratories
Chemistry · 38d
Cleared Sep 07, 1990
ABBOTT IMX FREE T4
K902834 · CEC
Abbott Laboratories
Chemistry · 71d
Cleared Aug 27, 1990
LIFECARE(R) MODEL 3 PUMP
K900468 · FRN
Abbott Laboratories
General Hospital · 208d
Cleared Aug 27, 1990
LIFECARE MODEL 4 PUMP
K900467 · FRN
Abbott Laboratories
General Hospital · 208d
Cleared Aug 23, 1990
IMX B12
K903218 · LIG
Abbott Laboratories
Chemistry · 31d
Cleared Aug 23, 1990
LIFE SHIELD (DISPOSABLE PRESSURE INFUSOR)
K901225 · KZD
Abbott Laboratories
General Hospital · 162d