7 results
·
20ms
·
Sources: EU EUDAMED, US FDA
EDGE/VISTA SYSTEM ENHANCEMENT PACKAGE
FDA 510(k)
FDA Class 2
·Radiology
CANCELLOUS BONE SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
NOVAMETRIX MODEL 510
FDA 510(k)
FDA Class 2
·Cardiovascular
ADAPTA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·February 15, 2013
PRECISION TEST STRIPS
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 20, 2011
SYSTEM CONSOLE
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 29, 2014
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