20 results · 35ms · Sources: EU EUDAMED, US FDA

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FABRINAL SA

FDA registration
FABRINAL SA·2 products·🇨🇭 Switzerland

Tran Goniowash

FDA UDI
Fabrinal SA·EFABTG012·Tran Goniowash is a single-use irrigation cannu...

ERG-Jet

FDA UDI
Fabrinal SA·EFABF062·The ERG-Jet is a contact lens for performing an...

Tran Canula

FDA UDI
Fabrinal SA·EFABTC012·TranCanula is a single-use irrigation cannula f...

ENDO ANCHOR SYSTEM - HELI-FX AAA

FDA Adverse Event
Malfunction ·MEDTRONIC IRELAND·Product code OTD·August 26, 2024

ANEURX ADVANTAGE BIFURCATED STENT GRAFT - HYDRO

FDA Adverse Event
Injury ·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·August 26, 2024

ENDURANT II EXTENSION CUFF

FDA Adverse Event
Malfunction ·MEDTRONIC IRELAND·Product code MIH·August 26, 2024

ENDURANT II ILIAC STENT GRAFT

FDA Adverse Event
Malfunction ·MEDTRONIC IRELAND·Product code MIH·January 10, 2018

VALIANT CAPTIVIA

FDA Adverse Event
Death ·MEDTRONIC IRELAND·Product code MIH·January 13, 2017

ENDURANT STENT GRAFT

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code MIH·June 11, 2024

SICAT OPTIGUIDE

FDA Adverse Event
Injury ·SICAT GMBH & CO. KG·Product code NDP·September 7, 2016

ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS

FDA Adverse Event
Injury ·WILLIAM COOK EUROPE·Product code MIH·April 20, 2018

VARIABLE LOCK SCREW 4.75X15MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWJ·January 24, 2018

ENDO ANCHOR SYSTEM - HELI-FX AAA

FDA Adverse Event
Malfunction ·MEDTRONIC IRELAND·Product code OTD·December 20, 2019

ENDURANT IIS BIFURCATED STENT GRAFT

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code MIH·April 15, 2026

ENDURANT II ILIAC STENT GRAFT

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code MIH·April 15, 2026

ENDURANT

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code MIH·June 10, 2019

ENDO ANCHOR SYSTEM - HELI-FX AAA

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code OTD·April 15, 2026

TALENT CAPTIVIA FF

FDA Adverse Event
Malfunction ·MEDTRONIC IRELAND·Product code MIH·June 17, 2016

HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI or GTIN: 00813024010890, when connected to the HeartMate 3 Left Ventricular Assist System, REF 106524US, UDI or GTIN: 00813024013297, and 106524, UDI or GTIN: 00813024011712 - Product Usage: Provides power to the System Controller and pump. - Provides power to the System Monitor when it is connected to the Power Module. - Connects the System Monitor to the System Controller for monitoring purposes. - Echoes System Controller alarms. The Mobile Power Unit is for home or clinical use when the patient does not require monitoring using the System Monitor. The Mobile Power Unit is used when the patient is indoors, stationary, or sleeping. The System Controller and the Mobile Power Unit are connected through the Mobile Power Unit patient cable. The cable transfers power from the Mobile Power Unit to the System Controller.

FDA Recall
Terminated ·Thoratec Corp.·Product code DSQ·December 2, 2019