7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PolyLock Small Bone Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
CONTURA CAVITY MAINTENANCE CATHETER
FDA 510(k)
FDA Class 2
·Radiology
CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
ISOFLEX LEAD
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI·Product code DTB·January 11, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
4.5MM CORTEX SCREW SELF-TAPPING 46MM
FDA Adverse Event
Injury
·SYNTHES USA·Product code KTT·June 27, 2013
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