10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EyeBOX
FDA 510(k)
FDA Class 2
·Neurology
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776178703·Hern Ovum Fcp small
ASCENT POSTERIOR OCCIPITAL THORACIC (POCT) SYSTEM (TITANIUM & COBALT CHROME RODS)
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO: OASYS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LISS INSERT-GUIDE F/DIST-FEM R RADIOLUC
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code FZX·June 26, 2013
ENDURANT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·July 29, 2011
RESTORE RECHARGEABLE NEUROSTIMULATOR
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·September 26, 2008
SUBDURAL ELECTRODE
FDA Adverse Event
Malfunction
·AD-TECH MEDICAL INSTRUMENT CORP.·Product code GYC·August 18, 2025
TRUE METRIX AIR
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·September 24, 2020
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