GAS - BEUDAMED

Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of Blood Gas analysis This product is intended for in vitro diagnostic use, in the quality control of Blood Gas analysis. Target values and ranges are supplied for the following analytes: Calcium, Chloride, Glucose, Lactate, PCO2, pH, pO2, Potassium, Sodium and Total CO2.

FDA Enforcement

Class II ·Terminated·Randox Laboratories Ltd.·April 3, 2019

AMSORB PLUS PREFILLED G-CAN 1.0L; Carbon dioxide absorbent canister; Product codes AMAB3801 and AMAB3801GE. Used in anesthesia.

FDA Enforcement

Class I ·Terminated·Armstrong Medical Services Limited·September 22, 2021

Spinal Stabilization Technologies, Ltd

Manufacturer

🇮🇪 Ireland·1 Basic UDI-DI·1 Device·GMED SAS

LABORATOIRE PURESSENTIEL IRELAND LIMITED

Manufacturer

🇮🇪 Ireland·17 Basic UDI-DIs·17 Devices·GMED SAS

Sahajanand Medical Technologies Ireland Limited

Manufacturer

🇮🇪 Ireland·176 Basic UDI-DIs·176 Devices·DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, and DNV Product Assurance AS

PerQdisc Nucleus Replacement System

Device

EU MDD · Eu Md Class 2b ·Spinal Stabilization Technologies, Ltd·No longer on the market·2 countries

PURESSENTIEL RESPIRATOIRE HYGIENE NASALE SPRAY HYDRATANT 100 ML

Device

EU MDD · Eu Md Class 2a ·LABORATOIRE PURESSENTIEL IRELAND LIMITED·On the market·6 countries

PURESSENTIEL RESPIRATOIRE HYGIENE NASALE SPRAY JET FORT 100 ML

Device

EU MDD · Eu Md Class 2a ·LABORATOIRE PURESSENTIEL IRELAND LIMITED·On the market·6 countries