Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

107 results for "St Jude Medical"
1–24 of 107
Search insights Median review: 65d Cleared: 100% Top manufacturer: St Jude Medical Lead specialty: Cardiovascular
Cleared Jul 20, 2018
GuardianTM Burr Hole Cover System
K181382 · GXR
St Jude Medical
Neurology · 56d
Cleared Apr 23, 2018
EnSite Velocity Cardiac Mapping System v5.2
K172396 · DQK
St Jude Medical
Cardiovascular · 258d
Cleared Nov 02, 2017
myMerlin(TM) Mobile Application Model APP1001
K173232 · MXC
St Jude Medical
Cardiovascular · 29d
Cleared Dec 13, 2016
MediGuide Technology System
K162643 · DQK
St Jude Medical
Cardiovascular · 82d
Cleared Dec 13, 2016
Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor...
K160335 · DRF
St Jude Medical
Cardiovascular · 309d
Cleared Dec 13, 2016
AutoMark Module
K160218 · DQK
St Jude Medical
Cardiovascular · 319d
Cleared Dec 13, 2016
EnSite Precision Cardiac Mapping System v2.0
K160210 · DQK
St Jude Medical
Cardiovascular · 320d
Cleared Nov 22, 2016
Pacel Flow Directed Pacing Catheter
K161873 · LDF
St Jude Medical
Cardiovascular · 138d
Cleared Oct 21, 2016
Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0
K160187 · DQK
St Jude Medical
Cardiovascular · 268d
Cleared Oct 07, 2016
EnSite Velocity Surface Electrode Kit
K160186 · DQK
St Jude Medical
Cardiovascular · 254d
Cleared Jun 09, 2016
Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover
K152342 · GXR
St Jude Medical
Neurology · 295d
Cleared May 19, 2016
Nanostim Introducer Kit
K161102 · DYB
St. Jude Medical, Inc.
Cardiovascular · 30d
Cleared Oct 22, 2015
Pacel Bipolar Pacing Catheters
K152784 · LDF
St Jude Medical
Cardiovascular · 27d
Cleared Oct 22, 2015
WorkMate Claris System, WorkMate Claris System Display Plus
K151911 · DQK
St Jude Medical
Cardiovascular · 101d
Cleared Jul 15, 2015
St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology...
K151622 · DRF
St Jude Medical
Cardiovascular · 29d
Cleared Apr 01, 2015
St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology...
K150631 · DRF
St Jude Medical
Cardiovascular · 21d
Cleared Dec 18, 2014
CPS Direct MediGuide Enabled outer catheter
K142239 · DQY
St Jude Medical
Cardiovascular · 127d
Cleared Dec 18, 2014
CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner...
K142235 · DQY
St Jude Medical
Cardiovascular · 127d
Cleared Nov 13, 2014
CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS...
K142254 · DQX
St Jude Medical
Cardiovascular · 91d
Cleared Jun 06, 2014
ENSITE VELOCITY SYSTEM
K141050 · DQK
St Jude Medical
Cardiovascular · 44d
Cleared May 02, 2014
SWIFT-LOCK ANCHOR
K140272 · GZB
St Jude Medical
Neurology · 88d
Cleared Mar 11, 2014
ULTIMUM EV HEMOSTASIS INTRODUCER
K140327 · DYB
St Jude Medical
Cardiovascular · 29d
Cleared Sep 09, 2013
EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULE
K132073 · DQK
St Jude Medical
Cardiovascular · 68d
Cleared Aug 29, 2013
ENSITE VELOCITY SYSTEM
K130727 · DQK
St Jude Medical
Cardiovascular · 164d