29 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
×
Medtronic, DBS Extension Kit for Deep Brain Stimulation, Catalog # 7482, 37085, 37086. Rx Only, Manufactured in: Medtronic, Inc. Villalba, Puerto Rico. Medtronic¿ DBSTM Therapy for Parkinson's Disease - Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic DBS Therapy for Parkinson's Disease is indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication. STN/GPi target system components: ¿ Kinetra¿ Model 7428 or Soletra¿ Model 7426 Neurostimulator ¿ Activa¿ PC Model 37601, Activa RC Model 37612, Activa SC Model 37602, or Activa SC Model 37603 Neurostimulator ¿ Model 7482, Model 7482A, Model 7483, Model 37085, or Model 37086 Extension ¿ Model 3387 or Model 3389 Lead Medtronic DBS Therapy for Tremor - Unilateral thalamic stimulation of the ventral intermediate nucleus (VIM) using Medtronic DBS Therapy for Tremor is indicated for the suppression of tremor in the upper extremity. The system is intended for patients who are diagnosed with essential tremor or parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability. VIM target system components: ¿ Soletra Model 7426 Neurostimulator ¿ Activa PC Model 37601, Activa RC Model 37612, Activa SC Model 37602, or Activa SC Model 37603 Neurostimulator ¿ Model 7482, Model 7482A, Model 7483, Model 37085, or Model 37086 Extension ¿ Model 3387 or Model 3389 Lead.
FDA Enforcement
Class II
·Terminated·Medtronic Neuromodulation·December 26, 2012
MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
FDA Enforcement
Class II
·Ongoing·Globus Medical, Inc.·April 30, 2025
Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1870S
FDA Enforcement
Class II
·Ongoing·Globus Medical, Inc.·February 14, 2024
Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref : 6143.1834S
FDA Enforcement
Class II
·Ongoing·Globus Medical, Inc.·February 14, 2024
Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1842S
FDA Enforcement
Class II
·Ongoing·Globus Medical, Inc.·February 14, 2024
ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844
FDA Enforcement
Class II
·Ongoing·Globus Medical, Inc.·February 14, 2024
Globus Medical MicroFuse Putty, 2.5cc and 10cc. Product Usage: MicroFuse Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MicroFuse Bone Void Filleris a bone graft extender to be used with autogenous bone marrow aspirate or autograft
FDA Enforcement
Class II
·Terminated·Globus Medical, Inc.·November 6, 2013
ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 15¿
FDA Enforcement
Class II
·Terminated·Globus Medical, Inc.·September 2, 2020
ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 8¿
FDA Enforcement
Class II
·Terminated·Globus Medical, Inc.·September 2, 2020
ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 8¿
FDA Enforcement
Class II
·Terminated·Globus Medical, Inc.·September 2, 2020
ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 15¿
FDA Enforcement
Class II
·Terminated·Globus Medical, Inc.·September 2, 2020
ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8¿
FDA Enforcement
Class II
·Terminated·Globus Medical, Inc.·September 2, 2020
ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 15¿
FDA Enforcement
Class II
·Terminated·Globus Medical, Inc.·September 2, 2020
ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 8¿
FDA Enforcement
Class II
·Terminated·Globus Medical, Inc.·September 2, 2020
ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15¿
FDA Enforcement
Class II
·Terminated·Globus Medical, Inc.·September 2, 2020
ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 8¿
FDA Enforcement
Class II
·Terminated·Globus Medical, Inc.·September 2, 2020
ALTERA Spacer ALTERA Spacer, 10x26, 8-12mm, 8¿
FDA Enforcement
Class II
·Terminated·Globus Medical, Inc.·September 2, 2020
ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 15¿
FDA Enforcement
Class II
·Terminated·Globus Medical, Inc.·September 2, 2020
ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8¿
FDA Enforcement
Class II
·Terminated·Globus Medical, Inc.·September 2, 2020
ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15¿
FDA Enforcement
Class II
·Terminated·Globus Medical, Inc.·September 2, 2020