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

Filters: Neurology ×
196 results for "medtronic"
25–48 of 196
Search insights Median review: 89d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Aug 24, 2018
Solitaire 2 and Solitaire Platinum Revascularization Device
K181060 · POL
Medtronic Neurovascular
Neurology · 123d
Cleared May 15, 2017
IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece,...
K170312 · HBC
Medtronic Powered Surgical Solutions
Neurology · 103d
Cleared Apr 21, 2017
StealthConnect Remote Viewing, Planning and Collaboration System
K162655 · HAW
Medtronic Navigation, Inc.
Neurology · 210d
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 Dec 30, 2016
Cranial Reducing Tubes
K162604 · HAW
Medtronic Navigation, Inc.
Neurology · 102d
Cleared Nov 02, 2016
Durepair Dura Regeneration Matrix
K161370 · GXQ
Medtronic Neurosurgery
Neurology · 169d
Cleared Sep 14, 2016
StealthStation System with Cranial Software
K153660 · HAW
Medtronic Navigation, Inc.
Neurology · 268d
Cleared Apr 07, 2016
StrataMR Valves and Shunts
K152700 · JXG
Medtronic Neurosurgery
Neurology · 199d
Cleared Jun 11, 2015
Synergy Cranial
K150216 · HAW
Medtronic Navigation, Inc.
Neurology · 132d
Cleared Mar 25, 2015
STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER,...
K141833 · HAW
Medtronic Navigation, Inc.
Neurology · 261d
Cleared Mar 20, 2015
DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System
K142344 · HAW
Izi Medical Products, LLC
Neurology · 210d
Not Cleared Aug 22, 2014
Medtronic DUET External Drainage and Monitoring System
DEN120017 · PCB
Medtronic Neurosurgery
Neurology · 609d
Cleared Jul 25, 2014
STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM
K133444 · HAW
Medtronic Navigation, Inc.
Neurology · 255d
Cleared Aug 07, 2013
QUADCUT
K130608 · HAW
Medtronic Navigation, Inc.
Neurology · 153d
Cleared Feb 13, 2013
MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM
K123524 · JXG
Medtronic Neurosurgery
Neurology · 90d
Cleared Jan 11, 2013
POWEREASE SYSTEM
K123270 · HBE
Medtronic Sofamor Danek USA, Inc.
Neurology · 84d
Cleared Aug 27, 2012
TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE
K121264 · HBE
Medtronic Surgical Technologies
Neurology · 123d
Cleared Nov 18, 2011
MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER
K110560 · JXG
Medtronic Neurosurgery
Neurology · 263d
Cleared Oct 26, 2011
IPC POWEREASE SYSTEM
K111520 · HBE
Medtronic Xomed, Inc.
Neurology · 146d
Cleared Oct 26, 2010
MULTI-LEAD TRIALING CABLE MODEL 355531
K102523 · GZB
Medtronic, Inc.
Neurology · 54d
Cleared Aug 24, 2010
LEGEND POWER ADAPTER MODEL: 6475000
K101168 · HBB
Medtronic Sofamor Danek
Neurology · 120d
Cleared Sep 02, 2009
PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM
K091312 · JXG
Medtronic Neurosurgery
Neurology · 121d