12 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENDO GIA(TM) EXTRA LONG ADAPTER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DELTA XTEND
FDA UDI
DEPUY (IRELAND)·10603295523147·DELTA XTEND Lateralized Glenosphere +2mm Eccent...
DELTA XTEND
FDA UDI
DEPUY (IRELAND)·10603295523277·DELTA XTEND Lateralized Glenosphere +2mm Standa...
DELTA XTEND
FDA UDI
DEPUY (IRELAND)·10603295523574·DELTA XTEND Lateralized Glenosphere +2mm Eccent...
DELTA XTEND
FDA UDI
DEPUY (IRELAND)·10603295523222·DELTA XTEND Lateralized Glenosphere +2mm Standa...
SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE
FDA 510(k)
FDA Class 2
·Cardiovascular
SERRALAPG
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SORIN C5 SYSTEM WITH MAST ROLLER PUMP
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DWB·May 21, 2012
ASCENDQ
FDA Adverse Event
Injury
·TORNIER INC·Product code KWT·May 23, 2013
TOTAL ASR FEM IMP SIZE 51
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·October 1, 2014
INTRAFIX TIBIAL SHEATH INSERTER
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code HRX·June 20, 2011
Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025