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"
337–360 of 1,296
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 02, 2006
AXSYM DIGOXIN III
K061249 · KXT
Abbott Laboratories
Toxicology · 29d
Cleared May 05, 2006
GLUCOSE
K060383 · CFR
Abbott Laboratories
Chemistry · 80d
Cleared May 04, 2006
CARBON DIOXIDE
K060295 · KHS
Abbott Laboratories
Chemistry · 87d
Cleared May 03, 2006
TOTAL BILIRUBIN
K060574 · CIG
Abbott Laboratories
Chemistry · 58d
Cleared Apr 21, 2006
PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS
K060768 · JIN
Abbott Diabetes Care, Inc.
Chemistry · 30d
Cleared Mar 31, 2006
NEX-LINK SPINAL FIXATION SYSTEM ROD TO ROD CONNECTORS, MODELS 725, 726 SERIES
K060634 · MNI
Abbott Spine, Inc.
Orthopedic · 22d
Cleared Mar 09, 2006
FREE-STYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM, MODEL 11001
K051839 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 245d
Cleared Mar 06, 2006
ABBOTT SPINE UNIVERSAL CLAMP SYSTEM
K060009 · JDQ
Abbott Spine, Inc.
Orthopedic · 62d
Cleared Jan 13, 2006
Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+...
K053110 · JGS
I-Stat Corporation
Chemistry · 70d
Cleared Jan 06, 2006
NEX-LINK SPINAL FIXATION SYSTEM OPEN POLYAXIAL SCREWS, MODELS 2112, 2113,...
K052566 · MNI
Abbott Spine, Inc.
Orthopedic · 109d
Cleared Dec 23, 2005
INSULIN PUMP
K051041 · LZG
Abbott Diabetes Care, Inc.
General Hospital · 242d
Cleared Dec 16, 2005
ARCHITECT B12 CALIBRATORS
K053330 · JIT
Abbott Laboratories
Chemistry · 15d
Cleared Nov 07, 2005
ABBOTT SPINE, INC. SPINNAKER SYSTEM
K052638 · KNW
Abbott Spine, Inc.
Gastroenterology & Urology · 42d
Cleared Sep 14, 2005
THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM
K052454 · NTE
Abbott Vascular Devices
Cardiovascular · 8d
Cleared Sep 14, 2005
NEX-LINK SPINAL FIXATION SYSTEM VARIABLE CROSSLINK, MODEL 721-XX
K052247 · KWP
Abbott Spine, Inc.
Orthopedic · 27d
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