18 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CONCHA-COLUMN
FDA 510(k)
FDA Class 2
·Anesthesiology
Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit
FDA 510(k)
FDA Class 2
·Cardiovascular
PHASEAL - CLOSED SYSTEM FOR THE PREPARATION AND ADMINISTRATION OF PARENTERAL DRUGS
FDA 510(k)
FDA Class 2
·General Hospital
ALLEGRETTO WAVE EYE-Q
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code LZS·April 4, 2014
SOFTCLIX LANCET DEVICE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·July 13, 2007
WALLFLEX¿ ESOPHAGEAL
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code ESW·September 26, 2012
DENALI JUGULAR SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 27, 2023
DENALI JUGULAR SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·November 21, 2023
DENALI FEMORAL SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 10, 2023
DENALI FEMORAL SYSTEM
FDA Adverse Event
Injury
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 20, 2023
DENALI JUGULAR SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·October 26, 2023
DENALI FEMORAL SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 6, 2023
DENALI FEMORAL SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 20, 2023
DENALI FEMORAL SYSTEM
FDA Adverse Event
Injury
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 11, 2023
DENALI FEMORAL SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·November 7, 2023
DENALI FEMORAL SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·October 20, 2023
DENALI FEMORAL SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 9, 2023
Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.
FDA Enforcement
Class II
·Terminated·Abbott Vascular·October 3, 2012