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"
337–360 of 1,611
Search insights Median review: 79d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 28, 2015
VERTEX(r) Reconstruction System
K152338 · NKG
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 70d
Cleared Oct 27, 2015
CD HORIZON Spinal System
K152457 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 60d
Cleared Sep 18, 2015
Export Advance Aspiration Catheter
K152335 · DXE
Medtronic, Inc.
Cardiovascular · 30d
Cleared Aug 14, 2015
MASTERGRAFT Contain
K151172 · MQV
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 105d
Cleared Aug 14, 2015
XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole
K150728 · ERL
Medtronic Xomed, Inc.
Ear, Nose, Throat · 147d
Cleared Aug 07, 2015
Confida Adaptive Sheath
K152054 · DYB
Medtronic, Inc.
Cardiovascular · 15d
Cleared Aug 06, 2015
CAPSTONE Spinal System, CLYDESDALE Spinal System
K151128 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 100d
Cleared Aug 06, 2015
O-Arm O2 Imaging System
K151000 · OWB
Medtronic, Inc.
Radiology · 113d
Cleared Aug 06, 2015
Reveal LINQ
K150614 · MXD
Medtronic, Inc.
Cardiovascular · 149d
Cleared Aug 03, 2015
Medtronic Confida Brecker Guidewire
K150465 · DQX
Medtronic Core Valve, LLC
Cardiovascular · 161d
Cleared Jul 23, 2015
KYPHON ELEMENT Inflatable Bone Tamp
K151532 · HRX
Medtronic, Inc.
Orthopedic · 45d
Cleared Jul 22, 2015
Ventilation (Tympanostomy) Tubes
K151067 · ETD
Medtronic Xomed, Inc.
Ear, Nose, Throat · 92d
Cleared Jul 16, 2015
Uncoated Tubing and Connector Components
K151523 · DWF
Medtronic, Inc.
Cardiovascular · 41d
Cleared Jun 16, 2015
Navigated Disc Prep Instruments and CAPSTONE Trials
K150231 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 134d
Cleared Jun 11, 2015
Synergy Cranial
K150216 · HAW
Medtronic Navigation, Inc.
Neurology · 132d
Cleared Jun 11, 2015
DIVERGENCE-L Anterior/Oblique Lumbar Fusion System
K150135 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 141d
Cleared Jun 09, 2015
ELEVATE Spinal System
K142559 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 271d
Cleared May 27, 2015
Intersept Filtered Cardiotomy Reservoir
K151110 · DTN
Medtronic, Inc.
Cardiovascular · 30d
Cleared May 27, 2015
Medtronic Patient Asistant
K150117 · DSI
Medtronic, Inc.
Cardiovascular · 127d
Cleared May 22, 2015
SPINEDESIGN Spine Surgery Planning (Software Application)
K142648 · LLZ
Medtronic Sofamor Danek USA, Inc.
Radiology · 247d
Cleared May 21, 2015
PlasmaBlade UPPP and Suction Coagulator
K150297 · GEI
Medtronic Advanced Energy
General & Plastic Surgery · 104d
Cleared May 19, 2015
MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink...
K151236 · PJT
Medtronic Minimed, Inc.
Chemistry · 8d
Cleared May 08, 2015
Level Sensor, Level Sensor Tape
K150530 · DTW
Medtronic, Inc.
Cardiovascular · 67d
Cleared Apr 28, 2015
KYPHON (R) HV-R(R) Bone Cement
K150460 · NDN
Medtronic Sofamor Danck USA, Inc.
Orthopedic · 64d