8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
MATCHED COMPONENT SET FOR RADIOIMMUNO-
FDA 510(k)
FDA Class 1
·Clinical Chemistry
aprevo® anterior lumbar interbody fusion device with interfixation
FDA 510(k)
FDA Class 2
·Orthopedic
KINETIS Total Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
EMSYS SHL 3HOLE 50
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·October 6, 2025
NAVILYST MEDICAL/VAXCEL
FDA Adverse Event
Malfunction
·NAVILYST MEDICAL·Product code LJS·February 12, 2014
SM304 M-SERIES W/ZOOM
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code INK·October 25, 2012
PUMP MMT-522LNAH PRDGM INS CL EN ML
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code MDS·September 20, 2010
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018