FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

1,611 results for "Medtronic"
865–888 of 1,611
Search insights Median review: 79d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 05, 2004
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K040536 · MQP
Medtronic Sofamor Danek
Orthopedic · 64d
Cleared Apr 23, 2004
LIFEPAK 12
K040775 · MKJ
Medtronic Physio-Control Corp.
Cardiovascular · 28d
Cleared Apr 21, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K034056 · MNH
Medtronic Sofamor Danek
Orthopedic · 113d
Cleared Apr 08, 2004
MEDTRONIC MINIMED MMT-407C AMBULATORY INFUSION PUMP, MODEL MMT-407C
K040061 · FRN
Medtronic Minimed
General Hospital · 86d
Cleared Mar 31, 2004
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
K040583 · MNI
Medtronic Sofamor Danek
Orthopedic · 26d
Cleared Mar 26, 2004
EN CIRCLR AL ADJUSTABLE LOOP MAPPING CATHETER MODELS, 1045AL1, 1045AL2,...
K033050 · DRF
Medtronic Vascular
Cardiovascular · 179d
Cleared Mar 25, 2004
POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADS
K040568 · GZB
Medtronic Vascular
Neurology · 21d
Cleared Mar 19, 2004
MODIFICATION TO VERTE-STACK
K040422 · MQP
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared Mar 19, 2004
PEDIATRIC AORTIC ROOT CANNULA
K040173 · DWF
Medtronic Perfusion Systems
Cardiovascular · 53d
Cleared Mar 09, 2004
ARROWHEAD SPINAL SYSTEM
K032560 · NKB
Medtronic Sofamor Danek
Orthopedic · 202d
Cleared Feb 18, 2004
VERTE-STACK SPINAL SYSTEM
K040167 · MQP
Medtronic Sofamor Danek
Orthopedic · 23d
Cleared Feb 12, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K040072 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 29d
Cleared Jan 29, 2004
SPHERICAL TIP CORONARY OSTIAL CANNULA, MODEL 30011
K034058 · DWF
Medtronic Vascular
Cardiovascular · 30d
Cleared Jan 22, 2004
MEDTRONIC SELECTSITE DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59 AND C304-L69
K033989 · DQY
Medtronic Inc. Cardiac Rhythm Management
Cardiovascular · 30d
Cleared Jan 13, 2004
MEDTRONIC PS MEDICAL STRATA NSC VALVE AND SHUNT ASSEMBLIES WITH AND WITHOUT...
K033850 · JXG
Medtronic Neurosurgery
Neurology · 33d
Cleared Dec 15, 2003
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K033322 · MNH
Medtronic Sofamor Danek
Orthopedic · 61d
Cleared Dec 05, 2003
DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAND (MODEL 610B),...
K032810 · KRH
Medtronic Heart Valves
Cardiovascular · 87d
Cleared Dec 03, 2003
MODIFICATION TO EQUATION FIXATION SYSTEM
K033495 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Nov 14, 2003
AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE
K033468 · DTM
Medtronic Perfusion Systems
Cardiovascular · 11d
Cleared Nov 06, 2003
LIFEPAK 12, 20, 500, CR PLUS
K033275 · MKJ
Medtronic Physio-Control Corp.
Cardiovascular · 27d
Cleared Nov 06, 2003
DYNALOK CLASSIC SPINAL SYSTEM
K033271 · MNI
Medtronic Sofamor Danek
Orthopedic · 27d
Cleared Nov 05, 2003
SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SELECT CAP...
K033416 · DWF
Medtronic Perfusion Systems
Cardiovascular · 9d
Cleared Oct 31, 2003
MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL...
K033264 · DWF
Medtronic Perfusion Systems
Cardiovascular · 22d
Cleared Oct 30, 2003
PISCES Z QUAD LEAD MODEL, 3890, PISCES Z QUAD COMPACT LEAD MODEL, 3891,...
K033016 · GZB
Medtronic Neurological
Neurology · 34d