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