8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OMNI TiN Coated Apex Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
CD HORIZON® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074465418·SCREW 7191765 CDH HA COATED MA 7.5X65
KYPHON ANCHOR FACET SCREW SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
EBCARRYON BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TENDRIL ST
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, CRMD·Product code NVN·January 13, 2014
DEPUY ASR XL FEM IMP SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD.·Product code KXA·June 26, 2013
CAREASSIST BED
FDA Adverse Event
Malfunction
·HILL-ROM PLUVIGNER·Product code FNL·July 28, 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