7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES
FDA 510(k)
FDA Class 2
·Cardiovascular
InterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625; InterGard Woven Collagen Coated Vascular prostheses marketed under 510(k} #K970843 and K984294.
FDA Recall
Terminated
·Intervascular S.A.S. Zone Industrielle Athelia I La Ciotat Cedex France·Product code DSY·December 9, 2009
SYNTHES ADOLESCENT LATERAL ENTRY FEMORAL NAIL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Alians Fragment Specific
FDA 510(k)
FDA Class 2
·Orthopedic
O.B. ULTRA ABSORBENCY TAMPONS
FDA Adverse Event
Malfunction
·MONTREAL SAN PRO·Product code HEB·February 21, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·January 25, 2011
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 8, 2014