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"
73–96 of 107
Search insights Median review: 65d Cleared: 100% Top manufacturer: St Jude Medical Lead specialty: Cardiovascular
Cleared Nov 06, 2008
AGILIS NXT STEERABLE INTRODUCER
K083083 · DYB
St Jude Medical
Cardiovascular · 21d
Cleared Sep 16, 2008
EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2
K082279 · OCL
St Jude Medical
Cardiovascular · 36d
Cleared Sep 11, 2008
ENSITE FUSION DYNAMIC REGISTRATION TOOL
K082467 · DQK
St Jude Medical
Cardiovascular · 15d
Cleared Aug 27, 2008
ROLL-X GUIDEWIRE
K082304 · DQX
St Jude Medical
Cardiovascular · 14d
Cleared Aug 15, 2008
SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A...
K081365 · MXC
St Jude Medical
Cardiovascular · 92d
Cleared Jul 25, 2008
EPICOR ABLATION SYSTEM
K080292 · OCL
St Jude Medical
Cardiovascular · 172d
Cleared Jan 31, 2008
MODIFICATION TO PROXIS SYSTEM
K073563 · NFA
St Jude Medical
Cardiovascular · 43d
Cleared Dec 20, 2007
ENSITE FUSION DYNAMIC REGISTRATION TOOL
K071818 · DQK
St Jude Medical
Cardiovascular · 170d
Cleared Sep 13, 2007
BRK TRANSSEPTAL NEEDLE
K072278 · DRC
St Jude Medical
Cardiovascular · 28d
Cleared Aug 22, 2007
REFLEXION SPIRAL VARIABLE RADIUS CATHETER
K072012 · DRF
St Jude Medical
Cardiovascular · 30d
Cleared Jun 05, 2007
ACROSS TRANSSEPTAL ACCESS SYSTEM, 406977, 406978, 406979, 406980, 406981,...
K070417 · DYB
St Jude Medical
Cardiovascular · 113d
Cleared May 11, 2007
MODIFICATION TO PROXIS SYSTEM, MODEL EPS 101
K063638 · DQY
St Jude Medical
Cardiovascular · 155d
Cleared May 01, 2007
MODIFICATION TO: ENSITE SYSTEM, MODEL, EE3000
K070902 · DQK
St Jude Medical
Cardiovascular · 29d
Cleared Apr 06, 2007
STRADA CAROTID GUIDING SHEATH
K070166 · DYB
St Jude Medical
Cardiovascular · 78d
Cleared Oct 20, 2006
REFLEXION SPIRAL VARIABLE RADIUS CATHETER, MODEL 402804
K062251 · DRF
St Jude Medical
Cardiovascular · 78d
Cleared Sep 13, 2006
PROXIS SYSTEM, MODEL EPS101
K060651 · NFA
St Jude Medical
Cardiovascular · 184d
Cleared Aug 03, 2006
FAST-CATH HEMOSTASIS INTRODUCER AND TRANSSEPTAL INTRODUCER
K061015 · DYB
St Jude Medical
Cardiovascular · 112d
Cleared Aug 01, 2006
VENTURE WIRE CONTROL CATHETER, MODEL WCC
K061843 · DQY
St Jude Medical
Cardiovascular · 32d
Cleared Jul 14, 2006
CPS DIRECT PL PEELABLE OUTER GUIDE CATHETER
K061710 · DQY
St Jude Medical
Cardiovascular · 25d
Cleared Jul 12, 2006
AGILIS NXT STEERABLE INTRODUCER
K061363 · DYB
St Jude Medical
Cardiovascular · 57d
Cleared Mar 08, 2006
CPS AIM INNER CATHETER, MODELS 410140, 410141, 410142, 410144, 410145,...
K053217 · DQY
St Jude Medical
Cardiovascular · 111d
Cleared Feb 24, 2006
CPS DIRECT SL OUTER CATHETER
K053277 · DQY
St Jude Medical
Cardiovascular · 93d
Cleared Jan 19, 2006
LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN
K052575 · DRA
St Jude Medical
Cardiovascular · 122d
Cleared Dec 05, 2005
SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER
K052644 · DYB
St Jude Medical
Cardiovascular · 70d