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"
289–312 of 1,631
Search insights Median review: 79d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 15, 2017
IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece,...
K170312 · HBC
Medtronic Powered Surgical Solutions
Neurology · 103d
Cleared May 11, 2017
CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the...
K170679 · NKB
Medtronic Sofamor Danek
Orthopedic · 66d
Cleared May 01, 2017
StealthStation S8 Spine Software v1.0.0
K170011 · OLO
Medtronic Navigation
Orthopedic · 118d
Cleared Apr 21, 2017
StealthConnect Remote Viewing, Planning and Collaboration System
K162655 · HAW
Medtronic Navigation, Inc.
Neurology · 210d
Cleared Apr 14, 2017
Navigated ELEVATE Inserter, Navigated Disc Prep Instruments
K163581 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 115d
Cleared Apr 13, 2017
PlasmaBlade T
K170610 · GEI
Medtronic Advanced Energy
General & Plastic Surgery · 43d
Cleared Apr 04, 2017
CD HORIZON™ Fenestrated Screw Set
K170347 · NKB
Medtronic Sofamor Danek USA
Orthopedic · 60d
Cleared Mar 31, 2017
StealthStation S8 System Platforms and StealthStation Cranial Software
K162309 · HAW
Medtronic Navigation, Inc.
Neurology · 226d
Cleared Mar 28, 2017
MR8 Drill System
K163565 · HBC
Medtronic Powered Surgical Solutions
Neurology · 99d
Cleared Mar 23, 2017
Medtronic Legend Pneumatic
K163182 · HBB
Medtronic Powered Surgical Solutions
Neurology · 129d
Cleared Mar 20, 2017
CoreCath 2.7S
K170296 · GEI
Medtronic Advanced Energy
General & Plastic Surgery · 48d
Cleared Mar 17, 2017
Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface
K170583 · DTN
Medtronic, Inc.
Cardiovascular · 17d
Cleared Feb 28, 2017
CareLink SmartSync Device Manager - Pacing System Analyzer
K163008 · DTA
Medtronic, Inc.
Cardiovascular · 123d
Cleared Feb 27, 2017
Kyphon Xpede Bone Cement
K163032 · NDN
Medtronic, Inc.
Orthopedic · 119d
Cleared Feb 23, 2017
Medtronic Transportation/Sterilization Cassettes
K163279 · KCT
Medtronic Sofamor Danek USA, Inc.
General Hospital · 94d
Cleared Feb 23, 2017
Reveal LINQ
K162855 · MXD
Medtronic, Inc.
Cardiovascular · 134d
Cleared Feb 14, 2017
Reveal LINQ Insertable Cardiac Monitor
K163460 · MXD
Medtronic, Inc.
Cardiovascular · 67d
Cleared Feb 10, 2017
MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface,...
K162774 · DTR
Medtronic, Inc.
Cardiovascular · 130d
Cleared Feb 02, 2017
FlexCath Select Steerable Shealth and Dilator
K163268 · DYB
Medtronic Cryocath, LP
Cardiovascular · 73d
Cleared Feb 01, 2017
MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface
K162958 · DTR
Medtronic, Inc.
Cardiovascular · 100d
Cleared Dec 30, 2016
Cranial Reducing Tubes
K162604 · HAW
Medtronic Navigation, Inc.
Neurology · 102d
Cleared Dec 20, 2016
CD HORIZON® Spinal System
K163301 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d
Cleared Dec 14, 2016
SOVEREIGN® Spinal System
K162680 · OVD
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 79d
Cleared Dec 06, 2016
Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface
K162896 · DTZ
Medtronic, Inc.
Cardiovascular · 50d