5 results
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16ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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XP-XP Tibial Tray - Interlok 69 mm Item # 195754
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
MobileDiagnost wDR motorized portable diagnostic X-ray systems.
FDA Enforcement
Class II
·Terminated·Sedecal S.A.·February 11, 2015
Mobile wDR motorized portable diagnostic X-ray systems. Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.
FDA Enforcement
Class II
·Terminated·Sedecal S.A.·March 16, 2016
MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·April 26, 2017