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"
385–408 of 1,611
Search insights Median review: 79d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 18, 2014
Bio-Medicus Adult Cannulae and Introducer
K142673 · DWF
Medtronic, Inc.
Cardiovascular · 60d
Cleared Nov 06, 2014
FlexCath Select Steerable Sheath (10 French)
K142684 · DYB
Medtronic Cryocath, LP
Cardiovascular · 48d
Cleared Oct 27, 2014
CD HORIZON Spinal System
K142847 · NKB
Medtronic Sofamor Danck USA, Inc.
Orthopedic · 27d
Cleared Oct 24, 2014
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance...
K142784 · DTZ
Medtronic, Inc.
Cardiovascular · 28d
Cleared Oct 23, 2014
TRI-OPTIC MEASUREMENT CELL
K133157 · DRY
Medtronic, Inc.
Cardiovascular · 371d
Cleared Oct 21, 2014
CD HORIZON SPINAL SYSTEM
K141604 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 127d
Cleared Oct 06, 2014
NOVASHIELD INJECTABLE NASAL PACKING AND STENT
K141704 · LYA
Medtronic, Inc.
Ear, Nose, Throat · 104d
Cleared Oct 01, 2014
DIVERGENCE Anterior Cervical Fusion System
K142450 · ODP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Sep 26, 2014
CLYDESDALE(R) SPINAL SYSTEM
K133577 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 309d
Cleared Sep 05, 2014
MASTERGRAFT MATRIX EXT
K141824 · MQV
Medtronic Sofamor Danek, Inc.
Orthopedic · 60d
Not Cleared Aug 22, 2014
Medtronic DUET External Drainage and Monitoring System
DEN120017 · PCB
Medtronic Neurosurgery
Neurology · 609d
Cleared Aug 15, 2014
DLP SILICONE CORONARY ARTERY OSTIAL CANNULAE
K141951 · DWF
Medtronic, Inc.
Cardiovascular · 28d
Cleared Aug 15, 2014
NC EUPHORA RAPID EXCHANGE BALLOON DILATATION CATHETER
K141090 · LOX
Medtronic, Inc.
Cardiovascular · 109d
Cleared Aug 06, 2014
CD HORIZON SPINAL SYSTEM
K141494 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 61d
Cleared Jul 25, 2014
STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM
K133444 · HAW
Medtronic Navigation, Inc.
Neurology · 255d
Cleared Jul 17, 2014
SHILLA GROWTH GUIDANCE SYSTEM
K140750 · PGM
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 114d
Cleared Jul 14, 2014
CD HORIZON SPINAL SYSTEM
K141605 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d
Cleared Jul 09, 2014
DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM
K140417 · KWQ
Medtronic Sofamor Danek, Inc.
Orthopedic · 141d
Cleared Jun 12, 2014
AFFINITY PIXIE OXYGENATION SYSTEM WITH
K141233 · DTN
Medtronic, Inc.
Cardiovascular · 30d
Cleared Jun 12, 2014
COUGAR GUIDEWIRE, ZINGER GUIDWIRE, THUNDER GUIDEWIRE, PROVIA GUIDEWIRE,...
K140695 · DQX
Medtronic, Inc.
Cardiovascular · 85d
Cleared Jun 10, 2014
MASTERGRAFT PUTTY
K140374 · LYC
Medtronic Sofamor Danek USA, Inc.
Dental · 116d
Cleared Jun 06, 2014
UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING...
K140972 · LDF
Medtronic, Inc.
Cardiovascular · 51d
Cleared May 30, 2014
BIO-PROBE DISPOSABLE INSERT WITH
K132730 · DPT
Medtronic, Inc.
Cardiovascular · 269d
Cleared May 22, 2014
NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS
K140454 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 87d