5 results
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22ms
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Sources: EU EUDAMED, US FDA
G7 DUAL MOBILITY LINER 44MM F Product Usage: Intended for use in hip arthroplasty cases which involves the removal of the damaged joint and tissues to be replaced with artificial prosthesis. The result of the procedure is to relieve pain and restore a sense of normal function and mobility to the damaged joint.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·February 21, 2018
Proteus 235 Proton Therapy System for cancer treatment.
FDA Enforcement
Class II
·Terminated·Ion Beam Applications S.A.·November 5, 2014
Achilles Express Bone Sonometer
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·October 16, 2019
Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be used with Cassette-based immunofluorescent in vitro diagnostic assays . Sofia 2 is intended for professional and laboratory use.
FDA Enforcement
Class II
·Terminated·Quidel Corporation·April 4, 2018
Achilles Insight Bone Sonometer
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·October 16, 2019