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

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1,305 results for "abbott"
721–744 of 1,305
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 06, 1993
ABBOTT VISION THEOPHYLLINE IIA
K926245 · KLS
Abbott Laboratories
Toxicology · 143d
Cleared Apr 23, 1993
IVEX-HP96 EXTENDED LIFE FILTER SET
K920736 · FPB
Abbott Laboratories
General Hospital · 429d
Cleared Apr 07, 1993
LIFECARE 175 INFUSER -- MODIFICATION
K923829 · FRN
Abbott Laboratories
General Hospital · 259d
Cleared Feb 05, 1993
ABBOTT QUICKSTART LD-1, MODIFICATION
K925188 · JGF
Em Diagnostic Systems, Inc.
Chemistry · 120d
Cleared Jan 26, 1993
ABBOTT IMX T4
K925110 · CDX
Abbott Laboratories
Chemistry · 109d
Cleared Jan 13, 1993
IMX PAP
K925377 · JFH
Abbott Laboratories
Chemistry · 82d
Cleared Jan 04, 1993
ABBOTT TDX/TDXFLX TT4
K925109 · CDX
Abbott Laboratories
Chemistry · 87d
Cleared Dec 23, 1992
PANCRETEC PROVIDER INFUSION PUMP -- MODIFICAITON
K923601 · FRN
Abbott Laboratories
General Hospital · 176d
Cleared Dec 15, 1992
LIFESHIELD VIAL ADAPTER
K920737 · FMI
Abbott Laboratories
General Hospital · 300d
Cleared Nov 05, 1992
LIFESHIELD ANESTHESIA SET
K913982 · FPA
Abbott Laboratories
General Hospital · 427d
Cleared Sep 29, 1992
IMX(R) GLYCATED HEMOGLOBIN
K921831 · LCP
Abbott Laboratories
Hematology · 166d
Cleared Aug 27, 1992
ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINE
K922991 · LGS
Abbott Laboratories
Toxicology · 66d
Cleared Aug 25, 1992
FLEXIFLO COMPANION ENTERAL PUMP SETS AND CONTAINER
K921697 · KNT
Abbott Laboratories
Gastroenterology & Urology · 139d
Cleared Jul 22, 1992
ABBOTT STREP A CONTROLS
K922490 · GTY
Abbott Laboratories
Microbiology · 56d
Cleared Jul 16, 1992
TESTPACK PLUS STREP A
K922345 · GTZ
Abbott Laboratories
Microbiology · 58d
Cleared Jun 30, 1992
NUTRIMIX MICROCOMPOUNDER
K921365 · LHI
Abbott Laboratories
General Hospital · 102d
Cleared Jun 24, 1992
FLEXIFLO QUANTUM ENT. PUMP SETS AND ENT. NUT. CONT
K915735 · KNT
Abbott Laboratories
Gastroenterology & Urology · 187d
Cleared Jun 03, 1992
CARDIAC CATHERIZATION KIT
K914299 · DQO
Abbott Laboratories
Cardiovascular · 252d
Cleared May 07, 1992
IMX INSULIN
K920109 · CFP
Abbott Laboratories
Chemistry · 118d
Cleared Apr 14, 1992
FLEXIFLO OVER-THE-GUIDEWIRE GASTROSTOMY KIT
K915110 · KNT
Abbott Laboratories
Gastroenterology & Urology · 153d
Cleared Mar 30, 1992
HEMOMETRIX CONTINUOUS BLOOD GAS MONITORING SYSTEM
K920061 · CBZ
Abbott Laboratories
Anesthesiology · 83d
Cleared Mar 19, 1992
ABBOTT VERTEX ANALYZER
K920559 · JJJ
Abbott Laboratories
Chemistry · 41d
Cleared Mar 04, 1992
PANCRETEC PROVIDER(R) MODEL 5500 INFUS PUMP, MODIF
K913931 · FRN
Abbott Laboratories
General Hospital · 188d
Cleared Mar 02, 1992
ABBOTT QUICKSTART AMYLASE, #5AXX
K920583 · JFJ
Em Diagnostic Systems, Inc.
Chemistry · 21d