10 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VUMAX
FDA 510(k)
FDA Class 2
·Radiology
POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
SCANDINAVIAN IVF SCIENCES AB, GAMETE-100
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·December 10, 2018
AIR DERMATOME HANDPIECE
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL·Product code GFD·April 5, 2013
SHILEY
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TYCO HEALTHCARE·Product code BTO·June 13, 2008
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC·Product code GJS·April 8, 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