8 results
·
35ms
·
Sources: EU EUDAMED, US FDA
Meniscus Versaflex
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 13, 2007
Wound Treatment System (VHT-200)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FLOWRUNNER Aspiration System
FDA 510(k)
FDA Class 2
·Cardiovascular
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·September 19, 2011
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES·Product code MIH·December 5, 2008
X-ALT HIP
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code LPH·July 25, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025