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"
217–240 of 1,296
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 22, 2014
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
K141678 · NTE
Abbott Vascular
Cardiovascular · 29d
Cleared May 13, 2014
IMDX HSV-1/2 FOR ABBOTT M2000
K140198 · OQO
Intelligent Medical Devices, Inc.
Microbiology · 106d
Cleared May 09, 2014
ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG
K140354 · LSL
Abbott Molecular, Inc.
Microbiology · 86d
Cleared Feb 28, 2014
HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS
K130255 · PDJ
Abbott Laboratories
Chemistry · 392d
Cleared Feb 27, 2014
COMPACT INTUITIV
K133115 · HQC
Abbott Medical Optics, Inc.
Ophthalmic · 150d
Cleared Dec 24, 2013
FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM
K132511 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 134d
Cleared Oct 11, 2013
IMDX C.DIFFICILE FOR ABBOTT M2000
K132235 · OZN
Intelligent Medical Devices, Inc.
Microbiology · 85d
Cleared Sep 13, 2013
VYSIS D7S486/CEP 7 FISH PROBE KIT
K131508 · PFG
Abbott Molecular, Inc.
Pathology · 112d
Cleared Aug 21, 2013
IMDX FLU A/B AND RSV FOR ABBOTT M2000
K131584 · OCC
Intelligent Medical Devices, Inc.
Microbiology · 82d
Not Cleared Jul 29, 2013
VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)
DEN130010 · PDO
Abbott Molecular, Inc.
Pathology · 111d
Cleared Jul 17, 2013
IMDX VANR FOR ABBOTT M2000
K123753 · NIJ
Intelligent Medical Devices, Inc.
Microbiology · 223d
Cleared Jun 27, 2013
FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM
K130094 · NBW
Abbott Diabetes Care
Chemistry · 168d
Cleared Jun 05, 2013
ABBOTT CARBAMAZEPINE ASSAY
K123518 · KLT
Microgenics Corporation
Toxicology · 203d
Cleared Apr 26, 2013
ABBOTT PHENOBARBITAL ASSAY
K123271 · DLZ
Microgenics Corp.
Chemistry · 189d
Cleared Apr 05, 2013
FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001
K123089 · NBW
Abbott Laboratories
Chemistry · 186d
Cleared Feb 01, 2013
ARCHITECT TOTAL BILIRUBIN
K121985 · CIG
Abbott Laboratories
Chemistry · 210d
Cleared Jan 30, 2013
MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK...
K123279 · LOX
Abbott Vascular
Cardiovascular · 100d
Cleared Jan 29, 2013
PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY
K123067 · DQX
Abbott Vascular, Inc.
Cardiovascular · 120d
Cleared Jan 14, 2013
ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR
K123372 · JIX
Abbott Laboratories
Chemistry · 74d
Cleared Dec 21, 2012
ABBOTT PLEX-ID FLU ASSAY
K121003 · OCC
Abbott Laboratories
Microbiology · 263d
Cleared Dec 13, 2012
ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS...
K120936 · DKB
Microgenics Corporation
Toxicology · 260d
Cleared Nov 27, 2012
ABBOTT ARCHITECT FREE T4
K123379 · CEC
Abbott Laboratories
Chemistry · 26d
Cleared Nov 20, 2012
HI-TORQUE COMMAND GUIDE WIRE FAMILY
K122573 · DQX
Abbott Vascular, Inc.
Cardiovascular · 89d
Cleared Oct 15, 2012
LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE)
K121721 · HQC
Abbott Medical Optics, Inc.
Ophthalmic · 125d