10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BEAUTIFIL FLOW
FDA 510(k)
FDA Class 2
·Dental
UTERINE TENACLUM HOOK
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
STERILE EMG ELECTRODES
FDA 510(k)
FDA Class 2
·Physical Medicine
GRAFTON DBM
FDA Adverse Event
Injury
·MEDTRONIC EATONTOWN·Product code NUN·July 6, 2019
SYNERGY
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 10, 2013
WINGSPAN STENT SYSTEM
FDA Adverse Event
Death
·NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORP.·Product code NJE·May 21, 2008
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·April 12, 2011
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022