2,704 results · 27ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

ISE Na+/K+ Selectivity Check

Device
EU IVDR · Eu Ivd Class B ·Beckman Coulter Ireland Inc.·On the market·32 countries

ISE Na+/K+ Selectivity Check

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·Beckman Coulter Ireland Inc.·1 device

FILTERTEK, B.V. (AN ITW MEDICAL COMPANY)

FDA registration
FILTERTEK, B.V. (AN ITW MEDICAL COMPANY)·1 product·🇮🇪 Ireland

a-1-ANTITRYPSIN

Device
EU IVDR · Eu Ivd Class B ·Beckman Coulter Ireland Inc.·On the market·32 countries

A Supreme Left Size 1

Device
EU MDR · Eu Md Class 1 ·Trulife·On the market·19 countries

A Supreme Right Size 1

Device
EU MDR · Eu Md Class 1 ·Trulife·On the market·19 countries

Silk A Supreme Right Size 1

Device
EU MDR · Eu Md Class 1 ·Trulife·On the market·19 countries

Silk A Supreme Left Size 1

Device
EU MDR · Eu Md Class 1 ·Trulife·On the market·19 countries

PMD Device Solutions Ltd

Manufacturer
🇮🇪 Ireland·2 Basic UDI-DIs·5 Devices·SGS Belgium NV

Stafford-Miller (Ireland) Limited

Manufacturer
🇮🇪 Ireland·SGS Belgium NV

Idoman Teoranta

Manufacturer
🇮🇪 Ireland·2 Basic UDI-DIs·2 Devices·SGS Belgium NV

BOSTON SOFT AFO W/O STABILIZER SIZE ADULT A (1-2)

Device
EU MDR · Eu Md Class 1 ·Allard Support UK Ltd·On the market

a-1 ANTITRYPSIN

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·Beckman Coulter Ireland Inc.·1 device

RespiraSense

Device
EU MDD · Eu Md Class 2b ·PMD Device Solutions Ltd·On the market·1 country

Thermablate EAS

Device
EU MDD · Eu Md Class 2b ·Idoman Teoranta·On the market·16 countries

Thermablate EAS

Device
EU MDD · Eu Md Class 2b ·Idoman Teoranta·On the market·17 countries

The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2, Anti HTLV 1/2, Anti HCV, HBsAg, Anti HBc, and Anti Treponema pallidum IgG. The product is delivered as a liquid in a kit of 3 identical ready-to-use vials of 5 mL each.

FDA Enforcement
Class II ·Terminated·Randox Laboratories Ltd.·September 28, 2022

RespiraSense patient respiratory monitor system

Basic UDI-DI
EU MDD · Eu Md Class 2b ·PMD Device Solutions Ltd·1 device

Thermablate EAS Treatment Control Unit

Basic UDI-DI
EU MDD · Eu Md Class 2b ·Idoman Teoranta·1 device

Thermablate EAS Disposable Cartridge

Basic UDI-DI
EU MDD · Eu Md Class 2b ·Idoman Teoranta·1 device