7 results
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17ms
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Sources: EU EUDAMED, US FDA
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Country: Ireland
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Zimmer Orthopedic Mfg Ltd
FDA registration
Zimmer Orthopedic Mfg Ltd·9 products·🇮🇪 Ireland
Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121
FDA Enforcement
Class II
·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019
Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase, Calcium, Chloride, Cortisol, Creatinine, Glucose, hCG pregnancy, Magnesium, Microalbumin, Osmolality, pH, Phosphate Inorganic, Potassium, Protein Total, Sodium, Specific Gravity, Urea and Uric Acid (Urate) on clinical chemistry systems Catalog Number: UC5074
FDA Enforcement
Class II
·Ongoing·Randox Laboratories Ltd.·August 30, 2023
NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral condyle of the knee joint in Total Knee Arthroplasty.
FDA Enforcement
Class II
·Terminated·ZIMMER ORTHOPEDIC MFG LTD·February 28, 2018
Iskus Health Ltd
Importer
🇮🇪 Ireland·7 Manufacturers
KD Surgical Ltd
Importer
🇮🇪 Ireland·20 Manufacturers
European Healthcare & Device Solutions Ltd.
Authorized representative
🇮🇪 Ireland·66 Manufacturers·867 Devices