St Jude Medical - FDA 510(k) Cleared Devices
Recent clearances: GuardianTM Burr Hole Cover System, EnSite Velocity Cardiac Mapping System v5.2, myMerlin(TM) Mobile Application Model APP1001
105
Total
105
Cleared
0
Denied
FDA 510(k) Regulatory Record - St Jude Medical Cardiovascular ✕
96 devices
Cleared
Apr 23, 2018
EnSite Velocity Cardiac Mapping System v5.2
Cardiovascular
258d
Cleared
Nov 02, 2017
myMerlin(TM) Mobile Application Model APP1001
Cardiovascular
29d
Cleared
Dec 13, 2016
EnSite Precision Cardiac Mapping System v2.0
Cardiovascular
320d
Cleared
Dec 13, 2016
AutoMark Module
Cardiovascular
319d
Cleared
Dec 13, 2016
Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor...
Cardiovascular
309d
Cleared
Dec 13, 2016
MediGuide Technology System
Cardiovascular
82d
Cleared
Nov 22, 2016
Pacel Flow Directed Pacing Catheter
Cardiovascular
138d
Cleared
Oct 21, 2016
Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0
Cardiovascular
268d
Cleared
Oct 07, 2016
EnSite Velocity Surface Electrode Kit
Cardiovascular
254d
Cleared
Oct 22, 2015
WorkMate Claris System, WorkMate Claris System Display Plus
Cardiovascular
101d
Cleared
Oct 22, 2015
Pacel Bipolar Pacing Catheters
Cardiovascular
27d
Cleared
Jul 15, 2015
St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology...
Cardiovascular
29d
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