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"
265–288 of 1,622
Search insights Median review: 79d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 26, 2017
CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System
K171107 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 165d
Cleared Sep 19, 2017
ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System,...
K172199 · MAX
Medtronic Sofamor Danek
Orthopedic · 60d
Cleared Sep 07, 2017
Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini
K170381 · GEI
Medtronic Advanced Energy
General & Plastic Surgery · 212d
Cleared Aug 21, 2017
INFINITY™ OCT System
K163375 · NKG
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 263d
Cleared Jul 06, 2017
CRESCENT™ Spinal System
K171031 · MAX
Medtronic Sofamor Danek
Orthopedic · 91d
Cleared Jul 03, 2017
NavLock Trackers
K171267 · OLO
Medtronic Navigation
Orthopedic · 63d
Cleared Jun 16, 2017
SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque...
K170191 · MCW
Medtronic Vascular, Inc.
Cardiovascular · 144d
Cleared Jun 13, 2017
FUSE Spinal System
K171468 · MAX
Medtronic Sofamor Danek
Orthopedic · 26d
Cleared Jun 13, 2017
Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette
K171427 · OTD
Medtronic Vascular, Inc.
Cardiovascular · 29d
Cleared Jun 02, 2017
Tubing Pack
K171308 · DWF
Medtronic, Inc.
Cardiovascular · 30d
Cleared May 25, 2017
Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492...
K171253 · LDF
Medtronic
Cardiovascular · 27d
Cleared May 19, 2017
StealthStationTM S8 ENT Software
K170018 · PGW
Medtronic Navigation, Inc.
Ear, Nose, Throat · 136d
Cleared May 19, 2017
DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
K162212 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 284d
Cleared May 16, 2017
TRANSLACE™ Spinal Tethering System
K163181 · OWI
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 183d
Cleared May 16, 2017
Kangaroo Feeding Tube with IRIS Technology
K163002 · KNT
Covidien (Dba Medtronic)
Gastroenterology & Urology · 200d
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