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"
361–384 of 1,305
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 01, 2005
COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS
K051264 · FPA
Unomedical A/S
General Hospital · 108d
Cleared Aug 29, 2005
THE SC-ACUFIX ANT-CER DYNAMIC CERVICAL PLATE SYSTEM SINGLE LEVEL PLATES
K052072 · KWQ
Abbott Spine, Inc.
Orthopedic · 28d
Cleared Aug 25, 2005
ULTRA HDL
K051962 · LBS
Abbott Laboratories
Chemistry · 37d
Cleared Aug 09, 2005
FREESTYLE CONNECT BLOOD GLUCOSE MONITORING SYSTEM
K051802 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 35d
Cleared Aug 03, 2005
ABBOTT AXSYM B12
K051327 · CDD
Abbott Laboratories
Chemistry · 75d
Cleared Jul 21, 2005
CELL-DYN SAPPHIRE SYSTEM
K051215 · GKZ
Abbott Laboratories
Hematology · 70d
Cleared Jun 27, 2005
FREESTYLE 600 BLOOD GLUCOSE MONITORING SYSTEM
K050500 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 119d
Cleared Jun 21, 2005
FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES)
K051519 · LIT
Abbott Laboratories (Perclose, Inc.)
Cardiovascular · 13d
Cleared Jun 08, 2005
IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER), 14677
K051125 · FZP
Abbott Laboratories
General & Plastic Surgery · 36d
Cleared May 27, 2005
PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS
K051213 · NBW
Abbott Laboratories, Inc.
Chemistry · 15d
Cleared May 20, 2005
XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
K050534 · FGE
Abbott Laboratories
Gastroenterology & Urology · 79d
Cleared Apr 07, 2005
ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY
K042411 · NRP
Axis-Shield , Ltd.
Toxicology · 212d
Cleared Mar 14, 2005
MODIFICATION TO: XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
K050501 · FGE
Abbott Vascular Devices
Gastroenterology & Urology · 14d
Cleared Feb 16, 2005
XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
K050103 · FGE
Abbott Laboratories
Gastroenterology & Urology · 29d
Cleared Oct 01, 2004
XPAND BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 20587,...
K041962 · FGE
Abbott Laboratories
Gastroenterology & Urology · 72d
Cleared Sep 29, 2004
ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA)
K041866 · CDZ
Axis-Shield Diagnostics, Ltd.
Chemistry · 82d
Cleared Sep 10, 2004
ABBOTT AXSYM TROPONIN-I ADV
K041811 · MMI
Abbott Laboratories
Chemistry · 66d
Cleared Aug 18, 2004
ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CONTROL...
K041687 · JJX
Abbott Laboratories
Chemistry · 57d
Cleared Aug 16, 2004
ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL...
K041194 · JJX
Medical Analysis Systems, Inc.
Chemistry · 102d
Cleared Jun 30, 2004
HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
K041550 · FRN
Abbott Laboratories
General Hospital · 21d
Cleared May 11, 2004
FOX PLUS PTA CATHETER
K040954 · LIT
Abbott Laboratories, Inc.
Cardiovascular · 28d
Cleared Apr 30, 2004
AXSYM CYCLOSPORINE
K040761 · MKW
Abbott Laboratories, Inc.
Chemistry · 36d
Cleared Apr 15, 2004
MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM
K040814 · NBW
Abbott Laboratories
Chemistry · 16d
Cleared Apr 07, 2004
XPERT BILIARY STENT, MODELS EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006,...
K040667 · FGE
Abbott Laboratories
Gastroenterology & Urology · 23d