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"
433–456 of 1,611
Search insights Median review: 79d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 01, 2013
PERIMETER INTERBODY FUSION DEVICE
K131669 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 147d
Cleared Oct 31, 2013
DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITHOUT PRESSURE MONITORING...
K132995 · DWF
Medtronic, Inc.
Cardiovascular · 37d
Cleared Oct 31, 2013
MEDTRONIC EXTERNAL PULSE GENERATOR (EPG)
K132924 · DTE
Medtronic, Inc.
Cardiovascular · 43d
Cleared Oct 28, 2013
AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE
K132972 · DTN
Medtronic, Inc.
Cardiovascular · 35d
Cleared Oct 22, 2013
5F & 6F LAUNCHER GUIDE CATHETER, 5F SHERPA ACTIVE NX GUIDE CATHETER, 6F Z4...
K132673 · DQY
Medtronic, Inc.
Cardiovascular · 56d
Cleared Oct 08, 2013
CD HORIZON SPINAL SYSTEM
K132471 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 62d
Cleared Oct 04, 2013
THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES
K132645 · GAD
Medtronic, Inc.
General & Plastic Surgery · 42d
Cleared Oct 03, 2013
MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT
K131673 · MQV
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 118d
Cleared Sep 27, 2013
MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING
K132030 · DYB
Medtronic, Inc.
Cardiovascular · 88d
Cleared Sep 26, 2013
PERIMETER INTERBODY FUSION DEVICE
K132700 · MAX
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Sep 23, 2013
T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE
K131888 · MQP
Medtronic Sofamor Danek, Inc.
Orthopedic · 90d
Cleared Sep 23, 2013
ANATOMIC PEEK CERVICAL FUSION SYSTEM
K130177 · ODP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 241d
Cleared Aug 14, 2013
NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER
K131425 · OLO
Medtronic Navigation, Inc.
Orthopedic · 89d
Cleared Aug 07, 2013
QUADCUT
K130608 · HAW
Medtronic Navigation, Inc.
Neurology · 153d
Cleared Aug 06, 2013
CD HORIZON SPINAL SYSTEM
K132111 · NKB
Medtronic Sofamor Danek USA
Orthopedic · 28d
Cleared Jul 30, 2013
6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT,...
K132008 · DTD
Medtronic, Inc.
Cardiovascular · 29d
Cleared Jul 25, 2013
CAPSTONE(R) SPINAL SYSTEM
K123027 · MAX
Medtronic Sofamor Danek, Inc.
Orthopedic · 300d
Cleared Jul 24, 2013
BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE
K131964 · DWA
Medtronic, Inc.
Cardiovascular · 27d
Cleared Jul 16, 2013
EXPORT ADVANCE ASPIRATION CATHETER
K130536 · QEZ
Medtronic, Inc.
Cardiovascular · 137d
Cleared Jul 10, 2013
DLP CORONARY OSTIAL PERFUSION CANNULAE
K131269 · DWF
Medtronic, Inc.
Cardiovascular · 68d
Cleared Jun 05, 2013
CD HORIZON SPINAL SYSTEM
K131321 · OSH
Medtronic Sofamor Danek USA
Orthopedic · 28d
Cleared Jun 04, 2013
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
K130640 · KWQ
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 85d
Cleared Apr 26, 2013
SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATING
K123990 · DYB
Medtronic Vascular
Cardiovascular · 121d
Cleared Apr 19, 2013
MASTERGRAFT STRIP
K130335 · MQV
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 67d