FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

1,299 results for "abbott"
361–384 of 1,299
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Mar 25, 2004
PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM
K040628 · NBW
Abbott Laboratories
Chemistry · 15d
Cleared Feb 17, 2004
WAVEMAX BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM
K033909 · FGE
Abbott Laboratories
Gastroenterology & Urology · 62d
Cleared Jan 30, 2004
ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME...
K033606 · NBC
Axis-Shield Diagnostics, Ltd.
Chemistry · 74d
Cleared Jan 29, 2004
ABBOTT DATA PORT PC, MODEL 12181
K040114 · FRN
Abbott Laboratories
General Hospital · 9d
Cleared Jan 08, 2004
PRECISION XCEED DIABETES MONITORING SYSTEM
K033845 · NBW
Abbott Laboratories
Chemistry · 28d
Cleared Dec 19, 2003
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES...
K031260 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 242d