10,000 results
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56ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RESUME
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code GZF·September 21, 2007
CNS-6801A
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·February 27, 2020
PENTA 3MM LEAD, 60 CM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·February 22, 2018
AXXESS QUAD LEAD, 3/6MM, 60CM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code GZB·April 25, 2025
AXXESS QUAD LEAD, 3/6MM, 60CM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code GZB·April 24, 2025
OCTRODE LEAD KIT, 60CM LENGTH
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code LGW·September 9, 2022
SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·June 16, 2014
ALGOVITA SPINAL CORD STIMULATION
FDA Adverse Event
Injury
·NUVECTRA·Product code LGW·July 8, 2016
ALGOVITA SPINAL CORD STIMULATION
FDA Adverse Event
Injury
·NUVECTRA·Product code LGW·July 28, 2016
CNS-6801A
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·September 30, 2019
CNS-6801A
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·October 2, 2019
Medtronic Model 37711 Restore Neurostimulator. The Restore Neurostimulator is an implanted, rechargeable neurostimulator which provides pain management therapy.
FDA Recall
Terminated
·Medtronic Inc, Neurological & Spinal Division·Product code GZB·November 22, 2005
Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation.
FDA Recall
Terminated
·St. Jude Medical, Inc.·Product code GZB·July 29, 2014
Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation.
FDA Recall
Terminated
·St. Jude Medical, Inc.·Product code GZB·July 29, 2014
Swift-Lock (TM) Anchor Accessory Kit, Directions For Use Model 1192, ANS, A St. Jude Medical Company. Product is intended to be used as an accessory to the leads component of ANS SCS systems, functioning to secure the lead to the fascia or interspinous/supraspinous ligament.
FDA Recall
Terminated
·Advanced Neuromodulation Systems, Inc·Product code GZB·February 22, 2010
Medtronic SPECIFY, 3998, Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at Medtronic, Inc., Villalba, Puerto Rico, USA. Contents of the inner package are STERILE. Method of sterilization: Ethylene Oxide. Model 3998 lead is an implantable, permanent lead. It is used to deliver electrical pulses to the dorsal aspect of the spinal cord. The lead consists of two polyurethane lead bodies joined to one silicone rubber paddle. The lead has two parallel rows of four platinum iridium electrodes on the distal end.
FDA Recall
Terminated
·Medtronic Neuromodulation·Product code GZB·May 21, 2008
Stimulator, Spinal-Cord, Implanted (Pain Relief)
FDA classification
FDA Class 2
·Stimulator, Spinal-Cord, Implanted (Pain Relief)
OCTRODE LEAD KIT, 60CM LENGTH
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·December 7, 2016
SWIFT-LOCK ANCHOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·November 1, 2016
OCTRODE LEAD KIT, 60CM LENGTH
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·October 14, 2016