Medtronic Neurosurgery is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Medtronic Neurosurgery - FDA 510(k) Cleared Devices
Recent clearances: Duet External Drainage and Monitoring System (EDMS), Duet External Drainage and Monitoring System (EDMS), StrataMR II Valves and Shunts
28
Total
27
Cleared
1
Denied
Medtronic Neurosurgery has 27 FDA 510(k) cleared neurology devices. Based in Goleta, US.
Latest FDA clearance: Mar 2025. Active since 2001.
Browse the complete list of FDA 510(k) cleared neurology devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Medtronic Neurosurgery
28 devices
Cleared
Mar 10, 2025
Duet External Drainage and Monitoring System (EDMS)
Neurology
103d
Cleared
Oct 24, 2024
Duet External Drainage and Monitoring System (EDMS)
Neurology
105d
Cleared
Sep 16, 2021
StrataMR II Valves and Shunts
Neurology
27d
Cleared
Oct 01, 2018
StrataMR guider tool
Neurology
103d
Cleared
Nov 02, 2016
Durepair Dura Regeneration Matrix
Neurology
169d
Cleared
Apr 07, 2016
StrataMR Valves and Shunts
Neurology
199d
Not Cleared
Aug 22, 2014
Medtronic DUET External Drainage and Monitoring System
Neurology
609d
Cleared
Feb 13, 2013
MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM
Neurology
90d
Cleared
Nov 18, 2011
MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER
Neurology
263d
Cleared
Sep 02, 2009
PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM
Neurology
121d
Cleared
Nov 20, 2008
STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY,...
Neurology
35d
Cleared
Aug 27, 2008
STRATA NSC BURR HOLE VALVE, MODEL 42335
Neurology
29d