9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NONE
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code UNK·December 11, 2009
MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR
FDA 510(k)
FDA Class 2
·Orthopedic
TENOR SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC.·Product code KWQ·December 11, 2009
FLEXIFO ENTERAL NUTRITION PUMP
FDA 510(k)
FDA Class 2
·General Hospital
Venus Legacy Pro Device
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COAGUCHEK® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·March 6, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·August 8, 2014
REVEAL DX
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DSI·February 15, 2011
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026