34 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Country: Ireland
×
Aerogen Ltd
Manufacturer
🇮🇪 Ireland·5 Basic UDI-DIs·5 Devices·National Standards Authority of Ireland (NSAI)
Medifill Ltd
Manufacturer
🇮🇪 Ireland·2 Basic UDI-DIs·2 Devices·National Standards Authority of Ireland (NSAI)
Syncrophi Systems Ltd
Manufacturer
🇮🇪 Ireland·1 Basic UDI-DI·1 Device·National Standards Authority of Ireland (NSAI)
CutisSeal Topical B
Device
EU MDD
·
Eu Md Class 2a
·Medifill Ltd·On the market·1 country
CutisSeal Topical H
Device
EU MDD
·
Eu Md Class 2a
·Medifill Ltd·On the market·1 country
KEWS300
Device
EU MDD
·
Eu Md Class 2b
·Syncrophi Systems Ltd·On the market·1 country
Aerogen USB Controller
Device
EU MDD
·
Eu Md Class 2a
·Aerogen Ltd·On the market·7 countries
Aerogen USB Controller
Device
EU MDD
·
Eu Md Class 2a
·Aerogen Ltd·On the market·1 country
Aerogen Ultra (10 Pack)
Device
EU MDD
·
Eu Md Class 2a
·Aerogen Ltd·On the market·1 country
Aerogen Solo Adult T-Piece 22mm
Device
EU MDD
·
Eu Md Class 2a
·Aerogen Ltd·On the market·13 countries
Aerogen Solo Nebuliser (10 Pack)
Device
EU MDD
·
Eu Md Class 2a
·Aerogen Ltd·On the market·25 countries
Solarice Rapid Exchange Balloon Dilatation Catheter, Product Numbers: SLC1506X, SLC1510X, SLC1512X, SLC1515X, SLC1520X, SLC2006X, SLC2010X, SLC2012X, SLC2015X, SLC2020X, SLC2025X, SLC2030X, SLC22510X, SLC22515X, SLC22520X, SLC22525X, SLC2506X, SLC2510X, SLC2512X, SLC2515X, SLC2520X, SLC2525X, SLC2530X, SLC27512X, SLC27515X, SLC27520X, SLC3010X, SLC3012X, SLC3015X, SLC3020X, SLC3025X, SLC3030X, SLC3506X, SLC3510X, SLC3512X, SLC3515X, SLC3520X, SLC3530X, SLC4010X, SLC4012X, SLC4015X, SLC4020X, SLC4025X, SLC4030X (OUS DISTRIBUTION ONLY)
FDA Enforcement
Class II
·Ongoing·Medtronic Vascular Galway DBA Medtronic Ireland·October 23, 2019
Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.
FDA Enforcement
Class II
·Terminated·Medtronic Vascular Galway DBA Medtronic Ireland·September 27, 2017
KEWS300
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Syncrophi Systems Ltd·1 device
CutisSeal Topical B
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Medifill Ltd·1 device
CutisSeal Topical H
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Medifill Ltd·1 device
AG-AS3200
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Aerogen Ltd·1 device
AG-AS3010
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Aerogen Ltd·1 device
AG-UC1000-NE
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Aerogen Ltd·1 device
AG-UC1000-IN
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Aerogen Ltd·1 device