Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

1,631 results for "medtronic"
217–240 of 1,631
Search insights Median review: 79d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 06, 2019
Capstone Control™ Spinal System
K190165 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 95d
Cleared Apr 30, 2019
Medtronic Model 5392 External Pulse Generator (EPG)
K190825 · DTE
Medtronic, Inc.
Cardiovascular · 29d
Cleared Apr 23, 2019
EverCrossTM 0.035 OTW PTA Dilatation Catheter
K190753 · LIT
Medtronic, Inc. (Formerly D.B.A. Ev3,...
Cardiovascular · 29d
Cleared Apr 12, 2019
Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface,...
K183490 · DTZ
Medtronic, Inc.
Cardiovascular · 116d
Cleared Apr 04, 2019
PYRAMESH™ Implant System
K183197 · MQP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 136d
Cleared Apr 03, 2019
Bio-Medicus Insertion Kit
K190557 · DWF
Medtronic, Inc.
Cardiovascular · 29d
Cleared Mar 22, 2019
Telescope Guide Extension Catheter
K183353 · DQY
Medtronic, Inc.
Cardiovascular · 109d
Cleared Mar 18, 2019
Affinity Pixie™ Oxygenator with Balance™ Biosurface (Model BBP211), Affinity...
K183511 · DTZ
Medtronic, Inc.
Cardiovascular · 90d
Cleared Mar 15, 2019
SelectSite C304-HIS Deflectable Catheter System
K183493 · DQY
Medtronic, Inc.
Cardiovascular · 88d
Cleared Mar 06, 2019
Visualase Thermal Therapy System
K181859 · LLZ
Medtronic Navigation, Inc.
Neurology · 237d
Cleared Mar 04, 2019
VS3-IR
K183453 · OWN
Medtronic
General & Plastic Surgery · 81d
Cleared Feb 15, 2019
EndoFLIP System
K183072 · FFX
Crospon, Ltd.
Gastroenterology & Urology · 102d
Cleared Feb 06, 2019
Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion...
K182885 · KWQ
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 114d
Cleared Jan 16, 2019
T2 STRATOSPHERE Expandable Corpectomy System
K183510 · MQP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Jan 15, 2019
OsteoCool RF Ablation System
K182497 · GEI
Medtronic Sofamor Danek USA, Inc.
General & Plastic Surgery · 125d
Cleared Jan 11, 2019
CD Horizon™ Spinal System
K182928 · NQP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 81d
Cleared Dec 19, 2018
Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation...
K182610 · OCL
Medtronic
Cardiovascular · 89d
Cleared Nov 26, 2018
FlexCath Advance Steerable Sheath and Dilator
K183174 · DRA
Medtronic Cryocath, LP
Cardiovascular · 10d
Cleared Nov 21, 2018
Heli-FX EndoAnchor System
K182957 · OTD
Medtronic Vascular, Inc.
Cardiovascular · 28d
Cleared Nov 08, 2018
CardioInsight Cardiac Mapping System
K181918 · DQK
Medtronic, Inc.
Cardiovascular · 113d
Cleared Nov 02, 2018
CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition
K182121 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 88d
Cleared Nov 02, 2018
NavLock Trackers, Robotic Reference Frame
K182104 · OLO
Medtronic Navigation
Orthopedic · 91d
Cleared Oct 19, 2018
DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure...
K182586 · DWF
Medtronic, Inc.
Cardiovascular · 29d
Cleared Oct 04, 2018
POWEREASE System
K182436 · HBE
Medtronic Sofamor Danek USA, Inc.
Neurology · 27d