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Name Classification Manufacturer Risk Class Country Source
Guardian™ Connect Application Medtronic Ireland HPRA
Vectris™ Lead Kits Medtronic Inc. Ireland HPRA
Animas® Vibe® Insulin Pump Animas Ireland HPRA
Access 2 / UniCel Dxl Systems Beckman Coulter Ireland HPRA
Riata and Riata ST silicone endocardial leads St. Jude Medical Ireland HPRA
Access 2 Immunoassay Systems Beckman Coulter Ireland HPRA
UniCel DxI Immunoassay Systems Beckman Coulter Inc. Ireland HPRA
Baxter Transfer Sets Baxter Healthcare Ireland HPRA
HomeChoice Disposable Sets / UV HomeChoice Automated PD Set with Cassette 4-Prong / HomeChoice Automated PD Set with Cassette 8-Prong / HomeChoice Automated PD Set with Cassette 4-Prong and Manifold Sets / 5-Prong Manifold Set with System II Connectors Baxter Healthcare Ireland HPRA
Spectra Optia® Apheresis System Terumo BCT Ireland HPRA
Maquet Oxygenators - Blood outlet connector Maquet Cardiopulmonary AG Ireland HPRA
Onyx Liquid Embolic System Covidien Ireland HPRA
Digital Accelerator Elekta Ireland HPRA
Puritan Bennett 840 Ventilator Covidien Ireland HPRA
Valisafe Bowie & Dick Type Test Product Code V3501020 Medisafe International Ireland HPRA
Trilogy® Acetabular System Shells Zimmer Ireland HPRA
Saver One Defibrillator AMI Italia Ireland HPRA
Animas 2020 and IR 1200 Insulin Pumps Animas Ireland HPRA
A-dec 200 Dental Chair System A-dec Inc. Ireland HPRA
Access 2 Immunoassay Systems / Synchron Lxi 725 Clinical Systems / UniCel DxC 600i Synchron Access Clinical Systems Beckman Coulter Inc Ireland HPRA
Procedure Pack rigid tip suction wand Pennine Healthcare Ireland HPRA
GlideScope Video Laryngoscope Verathon Medical (Europe) B.V. Ireland HPRA
AHM Gen II ELISA Beckman Coulter Inc Ireland HPRA
SYNCHRON® Systems Glucose (GLU) Cartridge Reagent Beckman Coulter Ireland HPRA
Mobilett Mira Siemens Healthcare Ireland HPRA