13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PHYSIOFLOW SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
TERUMO NEEDLE WITH LOCKING SHEATH
FDA 510(k)
FDA Class 2
·General Hospital
MYALLERGYTEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
LIFESTENT FLEXSTAR XL BILIARY STENT
FDA Adverse Event
Injury
·ANGIOMED GMBH & CO.·Product code FGE·November 21, 2008
LIFESTENT FLEXSTAR XL BILIARY STENT
FDA Adverse Event
Malfunction
·ANGIOMED GMBH & CO.·Product code FGE·November 5, 2008
LIFESTENT FLEXSTAR XL BILIARY STENT
FDA Adverse Event
Malfunction
·ANGIOMED GMBH & CO. MEDIZINTECHNIK·Product code FGE·February 20, 2009
LIFESTENT FLEXSTAR XL BILIARY STENT
FDA Adverse Event
Malfunction
·ANGIOMED GMBH & CO.·Product code FGE·November 4, 2008
LIFESTENT FLEXSTAR XL BILIARY STENT
FDA Adverse Event
Malfunction
·ANGIOMED GMBH & CO, MEDIZINTECHNIK·Product code FGE·February 13, 2009
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 10, 2013
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code MMI·April 15, 2011
BRACHYVISION
FDA Adverse Event
Injury
·VARIAN MEDICAL SYSTEMS·Product code MUJ·June 12, 2008
EVOLUT FX VALVE
FDA Adverse Event
Injury
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·July 9, 2025
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018