St Jude Medical - FDA 510(k) Cleared Devices
105
Total
105
Cleared
0
Denied
96 devices
Cleared
Oct 09, 2009
EP-WORKMATE SYSTEM, VERSION 4.2
Cardiovascular
28d
Cleared
Oct 08, 2009
ENGAGE/ENGAGE TR
Cardiovascular
48d
Cleared
Aug 27, 2009
SEGUIN ANNULOPLASTY RING
Cardiovascular
29d
Cleared
May 22, 2009
ENSITE SYSTEM, MODEL EE3000, AND ENSITE NAVX SURFACE ELECTRODE, MODEL EN0010
Cardiovascular
191d
Cleared
May 13, 2009
ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM
Cardiovascular
321d
Cleared
Apr 22, 2009
ULTIMUM/ENGAGE/ENGAGE TR
Cardiovascular
2d
Cleared
Apr 01, 2009
STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078
Cardiovascular
69d
Cleared
Jan 23, 2009
ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR
Cardiovascular
31d
Cleared
Jan 07, 2009
REFLEXION HD HIGH-DENSITY MAPPING CATHETER
Cardiovascular
349d
Cleared
Dec 15, 2008
AGILIS NXT STEERABLE INTRODUCER, MODEL G408322 AND G408323
Cardiovascular
27d
Cleared
Dec 12, 2008
CPS AIM SL SLITTABLE INNER CATHETER
Cardiovascular
72d
Cleared
Dec 09, 2008
AGILIS NXT STEERABLE INTRODUCER, MODEL G408324
Cardiovascular
180d
Cleared
Nov 06, 2008
AGILIS NXT STEERABLE INTRODUCER
Cardiovascular
21d
Cleared
Sep 16, 2008
EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2
Cardiovascular
36d
Cleared
Sep 11, 2008
ENSITE FUSION DYNAMIC REGISTRATION TOOL
Cardiovascular
15d
Cleared
Aug 27, 2008
ROLL-X GUIDEWIRE
Cardiovascular
14d
Cleared
Aug 15, 2008
SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A...
Cardiovascular
92d
Cleared
Jul 25, 2008
EPICOR ABLATION SYSTEM
Cardiovascular
172d
Cleared
Jan 31, 2008
MODIFICATION TO PROXIS SYSTEM
Cardiovascular
43d
Cleared
Dec 20, 2007
ENSITE FUSION DYNAMIC REGISTRATION TOOL
Cardiovascular
170d
Cleared
Sep 13, 2007
BRK TRANSSEPTAL NEEDLE
Cardiovascular
28d
Cleared
Aug 22, 2007
REFLEXION SPIRAL VARIABLE RADIUS CATHETER
Cardiovascular
30d
Cleared
Jun 05, 2007
ACROSS TRANSSEPTAL ACCESS SYSTEM, 406977, 406978, 406979, 406980, 406981,...
Cardiovascular
113d
Cleared
May 11, 2007
MODIFICATION TO PROXIS SYSTEM, MODEL EPS 101
Cardiovascular
155d
Cleared
May 01, 2007
MODIFICATION TO: ENSITE SYSTEM, MODEL, EE3000
Cardiovascular
29d
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