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

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