9 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PALFIQUE ESTELITE PASTE
FDA 510(k)
FDA Class 2
·Dental
DeltaForm HD
FDA UDI
Merz Dental GmbH·D7091980051·DeltaForm HighDefinition posterior; shade B1; s...
SPECIALIST
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295251576·SPECIALIST 2 OFFSET MODULAR PLUS TIBIAL TRAY TR...
VIRTUAL PORTS ENDOCLEAR SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
XSTAT 30, 1-Pack
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code FGE·February 21, 2013
MILLENIUM
FDA Adverse Event
Injury
·RESPIRONICS·Product code CAW·February 1, 2011
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·August 5, 2014
ANSPACH***Custom MCA5-1SD with Extended Exposure***Rx Only*** This device is intended to be used with Anspach Systems
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·July 2, 2014