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"
25–48 of 107
Search insights Median review: 65d Cleared: 100% Top manufacturer: St Jude Medical Lead specialty: Cardiovascular
Cleared Aug 15, 2013
AMPLATZER TORQ VUE LP DELIVERY SYSTEM
K131063 · DQY
St Jude Medical
Cardiovascular · 121d
Cleared Jun 18, 2013
MULTI LEAD TRIAL CABLE
K130545 · GZB
St Jude Medical
Neurology · 109d
Cleared May 03, 2013
ENSITE VELOCITY SYSTEM
K130594 · DQK
St Jude Medical
Cardiovascular · 57d
Cleared Mar 20, 2013
CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER
K130257 · DQY
St Jude Medical
Cardiovascular · 47d
Cleared Mar 20, 2013
CPS AIM UNIVERSAL SLITTABLE INNER CATHETER
K130252 · DQY
St Jude Medical
Cardiovascular · 47d
Cleared Feb 07, 2013
BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208
K122587 · DRC
St Jude Medical
Cardiovascular · 167d
Cleared Nov 28, 2012
SJM CONFIRM
K122161 · MXC
St Jude Medical
Cardiovascular · 131d
Cleared Jun 07, 2012
VIEWFLEX XTRA ICE CATHETER
K121381 · IYO
St Jude Medical
Radiology · 30d
Cleared May 03, 2012
ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER
K121006 · MTD
St Jude Medical
Cardiovascular · 30d
Cleared Apr 20, 2012
RAPID PROGRAMMER
K113611 · GZB
St Jude Medical
Neurology · 136d
Cleared Mar 19, 2012
RESPONSE ELECTROPHYSIOLOGY CATHETERS WITH LUMEN
K120544 · DRF
St Jude Medical
Cardiovascular · 25d
Cleared Mar 02, 2012
PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER
K113584 · DXO
St Jude Medical
Cardiovascular · 88d
Cleared Jan 18, 2012
ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL
K113773 · KRA
St Jude Medical
Cardiovascular · 27d
Cleared Nov 09, 2011
ENSITE VELOCITY SYSTEM V.3.0
K112688 · DQK
St Jude Medical
Cardiovascular · 55d
Cleared Jun 24, 2011
EPIDUCER LEAD DELIVERY SYSTEM
K110609 · LHG
St Jude Medical
Neurology · 113d
Cleared Jun 09, 2011
ENGAGE/ENGAGE TR INTRODUCERS
K111092 · DYB
St Jude Medical
Cardiovascular · 51d
Cleared May 10, 2011
AGILIS NXT STEERABLE INTRODUCER
K110450 · DYB
St Jude Medical
Cardiovascular · 83d
Cleared May 05, 2011
ENSITE VELOCITY SYSTEM
K110549 · DQK
St Jude Medical
Cardiovascular · 69d
Cleared Apr 08, 2011
AGILIS ES STEERABLE INTRODUCER
K103083 · DYB
St Jude Medical
Cardiovascular · 171d
Cleared Jan 26, 2011
VANTAGE VIEW SYSTEM
K110085 · DXJ
St Jude Medical
Cardiovascular · 15d
Cleared Dec 21, 2010
MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180
K101982 · DTA
St Jude Medical, Crmd
Cardiovascular · 160d
Cleared Oct 18, 2010
LIVEWIRE ELECTOPHYSIOLOGY CATHETER
K102721 · DRF
St Jude Medical
Cardiovascular · 27d
Cleared Oct 15, 2010
ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY...
K101955 · DRF
St Jude Medical
Cardiovascular · 95d
Cleared Sep 22, 2010
ENSITE VERISMO SEGMENTATION TOOL V.2.0
K101697 · LLZ
St Jude Medical
Radiology · 98d