28 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CARDIOSCOPE SONOPLUS 3000
FDA 510(k)
FDA Class 2
·Cardiovascular
N/A
FDA UDI
GEORGE TIEMANN & CO.·B58211260·CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY
RAICHEM CREATININE URINE STANDARD
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ZILVER 635 BILIARY SELF-EXPANDING STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·September 20, 2017
ZILVER 635 SELF-EXPANDING BILIARY STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·February 28, 2018
ZILVER 635 BILIARY SELF-EXPANDING STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·February 12, 2018
DEPUY ASR XL FEM IMP SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·April 10, 2013
VIBRANT SOUNDBRIDGE
FDA Adverse Event
Injury
·VIBRANT MED-EL HEARING TECHNOLOGY GMBH·Product code MPV·April 5, 2011
UNKNOWN DEPUY LAG SCREW
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HWC·May 21, 2008
ZILVER 635 BILIARY SELF-EXPANDING STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·May 25, 2011
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 BILIARY SELF-EXPANDING STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·January 4, 2018
Aquapak 640 SW, 650, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor .
FDA Enforcement
Class II
·Terminated·Teleflex Medical·July 16, 2014
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
Malfunction
·COOK IRELAND LTD·Product code FGE·December 12, 2017
ZILVER 635 BILIARY SELF EXPANDING STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·February 13, 2012
ZILVER 635 SELF-EXPANDING BILIARY STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·July 2, 2014