12 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POLARCUP DUAL MOBILITY SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Modulus
FDA UDI
Nuvasive, Inc.·00887517969385·Modulus TLIF-A Graft Packer
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 13, 2018
SAUFLON MULTIPURPOSE SOLUTION - NO RUB
FDA 510(k)
FDA Class 2
·Ophthalmic
VIVANT MEDICAL BIOPSY MARKER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LUX 1440
FDA Adverse Event
Malfunction
·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·April 16, 2013
LEICA TP1020
FDA Adverse Event
Injury
·LEICA BIOSYSTEMS GMBH·Product code IEO·April 19, 2011
6600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 9, 2008
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