10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARTHREX TENODESIS FAMILY
FDA 510(k)
FDA Class 2
·Orthopedic
MILLENIUM'S SKELITE SYNTHETIC RESORBABLE BONE VOID FILLER
FDA 510(k)
FDA Class 2
·Orthopedic
GEBAUER'S INSTANT ICE
FDA 510(k)
FDA Unclassified
·Unknown
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 10, 2013
ULTRAFLOW HCP 1.5F
FDA Adverse Event
Injury
·EV3 NEUROVASCULAR·Product code KRA·May 22, 2008
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 12, 2011
AERO LL FIXATION ANCHOR, 50MM
FDA Adverse Event
Malfunction
·STRYKER SPINE-US·Product code OVD·March 25, 2019
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