25 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Archer PSI System
FDA 510(k)
FDA Class 2
·Orthopedic
MasterSL femoral stem
FDA 510(k)
FDA Class 2
·Orthopedic
GUNTHER TULIP VENA CAVA FILTER SET
FDA 510(k)
FDA Class 2
·Cardiovascular
UNKNOWN
FDA Adverse Event
Malfunction
·COOK, INC.·Product code DTK·August 21, 2014
UNK
FDA Adverse Event
Injury
·COOK, INC.·Product code DTK·August 20, 2014
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code DTK·August 20, 2014
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·November 11, 2014
INFUSOMAT SPACE - US VERSION
FDA Adverse Event
Malfunction
·B. BRAUN MELSUNGEN AG·Product code FPA·August 19, 2011
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 23, 2013
GUNTHER TULIP VENA CAVA FILTER SET
FDA Adverse Event
Injury
·COOK INC·Product code DTK·April 3, 2026
GUNTHER TULIP FEMORAL VENA CAVA FILTER SET
FDA Adverse Event
Injury
·COOK INC·Product code DTK·December 5, 2017
GUNTHER TULIP FEMORAL VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DTK·November 1, 2017
GUNTHER TULIP VENA CAVA FILTER SET
FDA Adverse Event
Injury
·COOK INC·Product code DTK·November 4, 2025
GUNTHER TULIP FEMORAL VENA CAVA FILTER SET
FDA Adverse Event
Injury
·COOK INC·Product code DTK·February 27, 2018
GUNTHER TULIP FEMORAL VENA CAVA FILTER SET
FDA Adverse Event
Injury
·COOK INC·Product code DTK·May 5, 2017
GUNTHER TULIP FEMORAL VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DTK·May 12, 2017
UNKNOWN
FDA Adverse Event
Injury
·Product code DTK·August 20, 2020
UNK
FDA Adverse Event
Injury
·COOK, INC.·Product code DTK·August 20, 2014
UNK
FDA Adverse Event
Injury
·COOK, INC.·Product code DTK·August 26, 2014
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code DTK·October 26, 2022