7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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U2 Femoral Head
FDA 510(k)
FDA Class 2
·Orthopedic
BI-METRIC HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304254633·
FASTPACK TOTAL PSA METHOD VERIFICATION KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CUTTING EDGE SPINE INTERBODY FUSION DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES CARE INC.·Product code LZG·October 8, 2014
GYNECARE TVT SECUR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code PAH·June 11, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·July 15, 2011