Medical Device Manufacturer · US , Minnetonka , MN

St Jude Medical - FDA 510(k) Cleared Devices

105 submissions · 105 cleared · Since 2000
105
Total
105
Cleared
0
Denied

St Jude Medical has 105 FDA 510(k) cleared cardiovascular devices. Based in Minnetonka, US.

Historical record: 105 cleared submissions from 2000 to 2018.

Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.

105 devices
1–12 of 105
GuardianTM Burr Hole Cover System
K181382 · GXR Cover, Burr Hole · Neurology
Jul 2018 56d
EnSite Velocity Cardiac Mapping System v5.2
K172396 · DQK Computer, Diagnostic, Programmable · Cardiovascular
Apr 2018 258d
myMerlin(TM) Mobile Application Model APP1001
K173232 · MXC Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) · Cardiovascular
Nov 2017 29d
EnSite Precision Cardiac Mapping System v2.0
K160210 · DQK Computer, Diagnostic, Programmable · Cardiovascular
Dec 2016 320d
AutoMark Module
K160218 · DQK Computer, Diagnostic, Programmable · Cardiovascular
Dec 2016 319d
Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D
K160335 · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording · Cardiovascular
Dec 2016 309d
MediGuide Technology System
K162643 · DQK Computer, Diagnostic, Programmable · Cardiovascular
Dec 2016 82d
Pacel Flow Directed Pacing Catheter
K161873 · LDF Electrode, Pacemaker, Temporary · Cardiovascular
Nov 2016 138d
Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0
K160187 · DQK Computer, Diagnostic, Programmable · Cardiovascular
Oct 2016 268d
EnSite Velocity Surface Electrode Kit
K160186 · DQK Computer, Diagnostic, Programmable · Cardiovascular
Oct 2016 254d
Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover
K152342 · GXR Cover, Burr Hole · Neurology
Jun 2016 295d
WorkMate Claris System, WorkMate Claris System Display Plus
K151911 · DQK Computer, Diagnostic, Programmable · Cardiovascular
Oct 2015 101d

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