7 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HAP BIO-GROOVE TOTAL HIP PROSTH (BIO-INTERFACES)
FDA 510(k)
FDA Class 2
·Orthopedic
SOLARA JR. MANUAL WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
ENDOTRACHEAL TUBES - AIRWAY MANAGEMENT
FDA Adverse Event
Malfunction
·UNOMEDICAL SDN BHD·Product code BTR·May 13, 2014
ASR ACETABULAR CUPS 56
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·January 11, 2013
INTERA 1.5T
FDA Adverse Event
Injury
·PHILIPS MEDICAL SYSTEMS·Product code LNH·November 23, 2010
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019