18 results · 26ms · Sources: EU EUDAMED, 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