26 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SONOSITE HIGH-RESOLUTION DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES)
FDA 510(k)
FDA Class 2
·Radiology
TCI (TINNITUS CONTROL INSTRUMENT)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
FISHER & PAYKEL HEALTHECARE ORACLE ORAL MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
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
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 21, 2024
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS·Product code LYJ·April 9, 2013
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
UNKNOWN·Product code ITJ·August 28, 2014
VITALITY DS VR
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
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