FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

1,296 results for "Abbott"
313–336 of 1,296
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Feb 06, 2007
STARCLOSE HEX-HUB DILATOR
K062554 · DRE
Abbott Vascular, Inc.
Cardiovascular · 160d
Cleared Dec 14, 2006
COPILOT HEALTH MANAGEMENT SYSTEM
K062770 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 90d
Cleared Nov 22, 2006
CALCIUM
K062855 · CJY
Abbott Laboratories
Chemistry · 58d
Cleared Oct 17, 2006
FOX SV PTA CATHETER
K062843 · LIT
Abbott Laboratories
Cardiovascular · 25d
Cleared Sep 26, 2006
NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIES
K062505 · MNI
Abbott Spine, Inc.
Orthopedic · 29d
Cleared Jul 10, 2006
CELL-DYN RUBY SYSTEM
K061667 · GKZ
Abbott Laboratories
Hematology · 26d
Cleared Jul 07, 2006
STARCLOSE INTRODUCER SET MODEL- 1002
K060902 · DYB
Abbott Vascular, Inc.
Cardiovascular · 95d
Cleared Jun 23, 2006
CREATININE
K061193 · CGX
Abbott Laboratories, Inc.
Chemistry · 56d
Cleared Jun 14, 2006
ABBOTT AXSYM TROPONIN-I ADV
K060875 · MMI
Abbott Laboratories
Chemistry · 76d