7 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VANGUARD REMOVABLE MOLDED POLY TIBIA
FDA 510(k)
FDA Class 2
·Orthopedic
TIDI FACEMASK
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 22, 2014
GMK FEMORAL CUTTING GUIDE SIZE 6
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL, SA·Product code LXH·June 21, 2013
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·August 5, 2011
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018