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"
313–336 of 1,305
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 11, 2008
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
K081523 · NTE
Abbott Vascular-Vascular Solutions
Cardiovascular · 101d
Cleared Sep 11, 2008
ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH...
K080696 · DIP
Abbott Laboratories
Toxicology · 183d
Cleared Sep 05, 2008
PRECISION XCEED PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM WITH MODELS...
K080960 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 155d
Cleared Aug 29, 2008
UNIVERSAL CLAMP STAINLESS STEEL SYSTEM
K081622 · JDQ
Abbott Spine, Inc.
Orthopedic · 80d
Cleared Aug 19, 2008
RX ACCUNET LP EMBOLIC PROTECTION SYSTEM
K081549 · NTE
Abbott Laboratories
Cardiovascular · 77d
Cleared Aug 18, 2008
ABSOLUTE PRO .035 SELF-EXPANDING STENT SYSTEM
K072708 · FGE
Abbott Vascular-Vascular Solutions
Gastroenterology & Urology · 328d
Cleared Jul 10, 2008
ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT
K080739 · MKZ
Abbott Molecular, Inc.
Microbiology · 115d
Cleared Jul 10, 2008
WATER WORKS DOUCHING DEVICE
K080200 · HED
Abbott Research Group, Inc.
Obstetrics & Gynecology · 167d
Cleared Jun 04, 2008
FOXCROSS PTA CATHETER
K081417 · LIT
Abbott Vascular, Inc.
Cardiovascular · 15d
Cleared Apr 28, 2008
FOX PLUS PTA CATHETER
K080925 · LIT
Abbott Vascular, Inc.
Cardiovascular · 26d
Cleared Apr 11, 2008
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE
K072460 · DQX
Abbott Vascular, Inc.
Cardiovascular · 224d
Cleared Mar 26, 2008
MODIFICATION TO: FOX PLUS PTA CATHETER
K080264 · LIT
Abbott Vascular-Vascular Solutions
Cardiovascular · 54d
Cleared Mar 19, 2008
ACTIVATED ASPARTATE AMINOTRANSFERASE
K071525 · CIT
Abbott Laboratories
Chemistry · 289d
Cleared Jan 31, 2008
VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER
K072798 · LIT
Abbott Vascular-Vascular Solutions
Cardiovascular · 122d
Cleared Jan 30, 2008
ARDIS SPACER
K073202 · MAX
Abbott Spine, Inc.
Orthopedic · 78d
Cleared Jan 11, 2008
AVIATOR INSULIN PUMP
K071788 · LZG
Abbott Diabetes Care, Inc.
General Hospital · 193d
Cleared Dec 11, 2007
LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC
K072721 · DIF
Bio-Rad, Diagnostics Grp.
Chemistry · 76d
Cleared Nov 28, 2007
SEQUOIA SPINAL SYSTEM, MODEL 3300 SERIES
K072672 · NKB
Abbott Spine, Inc.
Orthopedic · 68d
Cleared Nov 01, 2007
THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS
K070984 · LFR
Abbott Diabetes Care, Inc.
Chemistry · 209d
Cleared Oct 23, 2007
FOX SV PTA CATHETER
K072824 · LIT
Abbott Laboratories
Cardiovascular · 21d
Cleared Sep 14, 2007
MODIFICATION TO RX HERCULINK ELITE BILIARY STENT SYSTEM
K063481 · FGE
Abbott Vascular, Inc.
Gastroenterology & Urology · 301d
Cleared Jul 25, 2007
PATHFINDER SYSTEM POLYAXIAL PEDICLE SCREWS
K071174 · NKB
Abbott Spine, Inc.
Orthopedic · 89d
Cleared Apr 16, 2007
ABBOTT ARCHITECT HAVAB-M
K063329 · LOL
Abbott Laboratories
Microbiology · 164d
Cleared Apr 10, 2007
FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM
K070850 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 13d