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"
49–72 of 107
Search insights Median review: 65d Cleared: 100% Top manufacturer: St Jude Medical Lead specialty: Cardiovascular
Cleared Sep 15, 2010
SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A
K101968 · MXC
St Jude Medical
Cardiovascular · 65d
Cleared Sep 07, 2010
6F ENGAGE/ENGAGE TR INTRODUCER
K101883 · DYB
St Jude Medical
Cardiovascular · 63d
Cleared Aug 13, 2010
INQUIRY AFOCUSII DIAGNOSTIC CATHETER
K101623 · DRF
St Jude Medical
Cardiovascular · 65d
Cleared Jul 14, 2010
ENSITE VELOCITY SYSTEM
K101328 · DQK
St Jude Medical
Cardiovascular · 64d
Cleared Jul 02, 2010
ENSITE VELOCITY SYSTEM REFERRED TO ENSITE VELOCITY SYSTEM WITH POSITIONAL...
K101667 · DQK
St Jude Medical
Cardiovascular · 18d
Cleared Jun 11, 2010
ENSITE VELOCITY SYSTEM, MODEL EE3000
K101419 · DQK
St Jude Medical
Cardiovascular · 22d
Cleared Jun 02, 2010
VIEWFLEX PLUS ICE CATHETER
K101239 · DQO
St Jude Medical
Cardiovascular · 30d
Cleared Apr 28, 2010
ROLL-X GUIDEWIRE
K100710 · DQX
St Jude Medical
Cardiovascular · 47d
Cleared Feb 25, 2010
ENSITE VELOCITY SYSTEM V1.3
K093942 · DQK
St Jude Medical
Cardiovascular · 65d
Cleared Dec 15, 2009
EP -NURSEMATE, EP -NURSEMATE WITH PHYSIO MODULE
K093583 · DQK
St Jude Medical
Cardiovascular · 26d
Cleared Nov 04, 2009
ENGAGE TR INTRODUCER
K093130 · DYB
St Jude Medical
Cardiovascular · 30d
Cleared Oct 16, 2009
SJM ATTUNE ANNULOPLASTY RING
K092876 · KRH
St Jude Medical
Cardiovascular · 28d
Cleared Oct 09, 2009
EP-WORKMATE SYSTEM, VERSION 4.2
K092810 · DQK
St Jude Medical
Cardiovascular · 28d
Cleared Oct 08, 2009
ENGAGE/ENGAGE TR
K092575 · DYB
St Jude Medical
Cardiovascular · 48d
Cleared Aug 27, 2009
SEGUIN ANNULOPLASTY RING
K092310 · KRH
St Jude Medical
Cardiovascular · 29d
Cleared May 22, 2009
ENSITE SYSTEM, MODEL EE3000, AND ENSITE NAVX SURFACE ELECTRODE, MODEL EN0010
K083328 · DQK
St Jude Medical
Cardiovascular · 191d
Cleared May 13, 2009
ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM
K081803 · DRF
St Jude Medical
Cardiovascular · 321d
Cleared Apr 22, 2009
ULTIMUM/ENGAGE/ENGAGE TR
K091137 · DYB
St Jude Medical
Cardiovascular · 2d
Cleared Apr 01, 2009
STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078
K090163 · DRB
St Jude Medical
Cardiovascular · 69d
Cleared Jan 23, 2009
ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR
K083835 · KRH
St Jude Medical
Cardiovascular · 31d
Cleared Jan 07, 2009
REFLEXION HD HIGH-DENSITY MAPPING CATHETER
K080179 · DRF
St Jude Medical
Cardiovascular · 349d
Cleared Dec 15, 2008
AGILIS NXT STEERABLE INTRODUCER, MODEL G408322 AND G408323
K083402 · DYB
St Jude Medical
Cardiovascular · 27d
Cleared Dec 12, 2008
CPS AIM SL SLITTABLE INNER CATHETER
K082932 · DQY
St Jude Medical
Cardiovascular · 72d
Cleared Dec 09, 2008
AGILIS NXT STEERABLE INTRODUCER, MODEL G408324
K081645 · DYB
St Jude Medical
Cardiovascular · 180d