7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IFA ANTI-NDNA
FDA 510(k)
FDA Class 2
·Immunology
MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DynaNail TTC Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
STEALTHSTATION S7 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 24, 2014
DISPOSABLE HEMOSTASIS CLIP
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code MND·September 25, 2012
CONTAK RENEWAL
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 27, 2010
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 25, 2014