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"
457–480 of 1,611
Search insights Median review: 79d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 10, 2013
CD HORIZON SPINAL SYSTEM
K130646 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 30d
Cleared Apr 09, 2013
CAPSTONE L SPINAL SYSTEM
K123978 · MAX
Medtronic Sofamor Danek USA
Orthopedic · 104d
Cleared Apr 09, 2013
ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE...
K123153 · DQY
Medtronic, Ireland
Cardiovascular · 182d
Cleared Apr 01, 2013
VERTEX RECONSTRUCTION SYSTEM, VERTEXT SELECT RECONSTRUCTION SYSTEM
K123906 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 103d
Cleared Apr 01, 2013
CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM
K123733 · OCL
Medtronic, Inc.
Cardiovascular · 117d
Cleared Mar 27, 2013
DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH AUTO-INFLATE CUFF
K123762 · DWF
Medtronic, Inc.
Cardiovascular · 110d
Cleared Mar 22, 2013
NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPS
K124004 · OLO
Medtronic Navigation, Inc.
Orthopedic · 86d
Cleared Mar 22, 2013
ANATOMIC PEEK CERVICAL FUSION SYSTEM CORNERSTONE PSR CERVICAL FUSION SYSTEM...
K122037 · MAX
Medtronic Sofamor Danek, Inc.
Orthopedic · 254d
Cleared Mar 19, 2013
AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE
K123351 · DTM
Medtronic Perfusion Systems
Cardiovascular · 139d
Cleared Mar 06, 2013
CLEARED UNDER GRAFTON II EDBM
K122513 · MBP
Medtronic Sofamor Danek, Inc.
Orthopedic · 201d
Cleared Feb 25, 2013
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
K123656 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 89d
Cleared Feb 22, 2013
CD HORIZON SPINAL SYSTEM
K123809 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 73d
Cleared Feb 13, 2013
MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM
K123524 · JXG
Medtronic Neurosurgery
Neurology · 90d
Cleared Jan 31, 2013
MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM)
K123691 · MQV
Medtronic Sofamor Danek, Inc.
Orthopedic · 59d
Cleared Jan 29, 2013
PACIFIC PLUS
K123358 · LIT
Medtronic Vascular
Cardiovascular · 90d
Cleared Jan 22, 2013
AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND CARMEDA...
K123314 · DTZ
Medtronic, Inc.
Cardiovascular · 89d
Cleared Jan 11, 2013
POWEREASE SYSTEM
K123270 · HBE
Medtronic Sofamor Danek USA, Inc.
Neurology · 84d
Cleared Jan 10, 2013
AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER
K123201 · GEI
Medtronic Advanced Energy, LLC
General & Plastic Surgery · 90d
Cleared Jan 10, 2013
MEDTRONIC XOMED, INC.
K122391 · LRK
Medtronic Xomed, Inc.
Dental · 156d
Cleared Jan 09, 2013
AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL...
K122914 · DTN
Medtronic, Inc.
Cardiovascular · 110d
Cleared Dec 27, 2012
FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH)
K123591 · DRA
Medtronic Cryocath, LP
Cardiovascular · 36d
Cleared Dec 21, 2012
KYPHON EXPRESS II INFLATABLE BONE TAMPS
K123771 · HRX
Medtronic
Orthopedic · 14d
Cleared Dec 18, 2012
VERTEX RECONSTRUCTION SYSTEM
K123568 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d
Cleared Dec 14, 2012
AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND BALANCE...
K122827 · DTZ
Medtronic, Inc.
Cardiovascular · 91d