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"
145–168 of 901
Search insights Median review: 61d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 08, 2001
STERILE PISTON SYRINGE
K002717 · FMF
Abbott Laboratories
General Hospital · 130d
Cleared Nov 13, 2000
SOF-TACT DIABETES MANAGEMENT SYSTEM
K001993 · LFR
Abbott Laboratories
Chemistry · 137d
Cleared Oct 05, 2000
SPIROL EPIDURAL CATHETER
K000886 · BSO
Abbott Laboratories
Anesthesiology · 199d
Cleared Aug 10, 2000
LIFESHIELD ADDITIVE PIERCING PIN
K002006 · FPA
Abbott Laboratories
General Hospital · 38d
Cleared Jul 27, 2000
MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE
K001616 · FOZ
Abbott Laboratories
General Hospital · 63d
Cleared Jul 20, 2000
ABBOTT ACCLAIM ENCORE STANDARD TUBING PUMP
K002126 · FRN
Abbott Laboratories
General Hospital · 6d
Cleared May 25, 2000
ABBOTT IMX GLYCATED HEMOGLOBIN II
K992085 · LCP
Abbott Laboratories
Hematology · 339d
Cleared Mar 24, 2000
ABBOTT GEMSTAR I.V. INFUSION PUMP - 7 THERAPY CONFIGURATION, 6 THERAPY...
K000821 · FRN
Abbott Laboratories
General Hospital · 10d
Cleared Dec 22, 1999
ABBOTT GEMSTAR I.V. INFUSION PUMP-7 THERAPY CONFIGURATION, ABBOTT GEMSTAR...
K994039 · FRN
Abbott Laboratories
General Hospital · 23d
Cleared Nov 24, 1999
ABBOTT ARCHITECH GLYCATED HEMOGLOBIN MASTERCHECK
K992710 · JJY
Abbott Laboratories
Immunology · 105d
Cleared Nov 01, 1999
ABBOTT ARCHITECT GLYCATED HEMOGLOBIN
K991483 · LCP
Abbott Laboratories
Hematology · 187d
Cleared Oct 25, 1999
ABBOTT AXSYM HOMOCYSTEINE
K992858 · LPS
Abbott Laboratories
Chemistry · 61d
Cleared Oct 05, 1999
ALCYON 300I (WITH ISE MODULE) ANALYZER
K993083 · CEM
Abbott Laboratories
Chemistry · 20d
Cleared Sep 24, 1999
MODIFICATION OF: CELL-DYN 1200 SYSTEM
K992444 · GKZ
Abbott Laboratories
Hematology · 64d
Cleared Aug 25, 1999
FLEXIFLO ENTERAL FEEDING TUBE
K992494 · KNT
Ross Product Div. Abbott Laboratories
Gastroenterology & Urology · 30d
Cleared Jul 09, 1999
CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700...
K991605 · GKZ
Abbott Laboratories
Hematology · 60d
Cleared Jun 23, 1999
CELL-DYN 1200 SYSTEM
K991142 · GKZ
Abbott Laboratories
Hematology · 79d
Cleared Jun 01, 1999
CRP
K991372 · DCN
Abbott Laboratories
Immunology · 42d
Cleared May 28, 1999
MODIFICATION TO ALCYON DIRECT BILIRUBIN
K991175 · CIG
Abbott Laboratories
Chemistry · 60d
Cleared May 13, 1999
ACCLAIM INFUSION PUMP
K991501 · FRN
Abbott Laboratories
General Hospital · 14d
Cleared May 11, 1999
ABBOTT ARCHITECT CEA
K990774 · DHX
Abbott Laboratories
Immunology · 63d
Cleared Apr 06, 1999
MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE
K990863 · KNT
Ross Product Div. Abbott Laboratories
Gastroenterology & Urology · 21d
Cleared Mar 08, 1999
RF
K990035 · DHR
Abbott Laboratories
Immunology · 61d
Cleared Feb 22, 1999
FACT PLUS ONE STEP PREGNANCY TEST
K990373 · LCX
Abbott Laboratories
Chemistry · 14d