4 results
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52ms
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Sources: EU EUDAMED, US FDA
Anteris Technologies Corporation
FDA registration
Anteris Technologies Corporation·1 product·🇺🇸 United States
NAMIC Custom Angiographic Kit, Right Heart Kit, REF/Catalog # 60190254, Sterile, and bulk Non-Sterile Manifolds Assemblies, Product #s 40338200 and 40336200 (foreign product for further processing, e.g., packaging, labeling, sterilization, and distribution under BSC). Manufactured by: Boston Scientific Corporation/NAMIC Technology Center/Glens Falls, New York 12801. Angiographic Manifolds are intended for use in fluid management and/or invasive pressure monitoring systems. Procedures in which angiographic manifold may be used include hemodynamic pressure monitoring and intra-arterial and intravenous administration of water based solutions or radiographic contrast media.
FDA Recall
Terminated
·Navilyst Medical·Product code DTZ·August 6, 2008
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices
RIOMAVIX LTD
Authorized representative
🇪🇸 Spain·400 Manufacturers·4531 Devices