FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

1,622 results for "medtronic"
289–312 of 1,622
Search insights Median review: 79d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
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
Cleared Nov 17, 2016
InTRAkit
K162097 · DYB
Medtronic Vascular
Cardiovascular · 111d
Cleared Nov 16, 2016
CD HORIZON® Spinal System
K162379 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 84d
Cleared Nov 15, 2016
Achieve Advance Mapping Catheter
K162892 · DRF
Medtronic, Inc.
Cardiovascular · 29d
Cleared Nov 02, 2016
Durepair Dura Regeneration Matrix
K161370 · GXQ
Medtronic Neurosurgery
Neurology · 169d
Cleared Oct 21, 2016
TRAcelet Compression Device
K162027 · DXC
Medtronic Vascular
Cardiovascular · 91d
Cleared Oct 18, 2016
Medtronic Temporary External Pacemaker 53401
K162054 · DTE
Medtronic, Inc.
Cardiovascular · 85d
Cleared Oct 14, 2016
HawkOne Directional Atherectomy System
K161361 · MCW
Medtronic Vascular, Inc.
Cardiovascular · 151d
Cleared Oct 12, 2016
Medtronic Model 5392 External Pulse Generator (EPG)
K162550 · DTE
Medtronic, Inc.
Cardiovascular · 29d
Cleared Oct 04, 2016
CD HORIZON® Spinal System
K162494 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 27d