28 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FUSION FAST
FDA 510(k)
FDA Class 2
·Dental
DELTA 2000 SERIES EXTRACORPOREAL LITHOTRIPTER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MAGNA TEK ESU-400
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BACT/ALERT® SN CULTURE BOTTLE
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC·Product code MDB·September 11, 2015
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·April 8, 2016
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·April 8, 2016
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·July 31, 2017
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 29, 2017
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 29, 2017
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 12, 2019
MX40 1.4 GHZ SMART HOPPING
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code DSI·March 13, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 28, 2011
CONTAK RENEWAL 3
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008
ZILVER 635 BILIARY SELF-EXPANDING STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·May 25, 2011
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·April 14, 2020
ZILVER 635 BILIARY SELF-EXPANDING STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD.·Product code FGE·April 11, 2011
ZILVER 635 BILIARY SELF-EXPANDING STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·September 5, 2012
ZILVER 635 SELF EXPANDING BILIARY STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·June 13, 2014
ZILVER 635 BILIARY SELF-EXPANDING STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·May 30, 2014
ZILVER 635 BILIARY SELF EXPANDING STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·February 13, 2012