80 results
·
40ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PENUMBRA SYSTEM / PENUMBRA SYSTEM MAX
FDA 510(k)
FDA Class 2
·Cardiovascular
PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·July 22, 2015
PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·June 18, 2015
PENUMBRA SYSTEM JETD REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·May 8, 2019
PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·July 17, 2015
PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·October 30, 2015
PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER
FDA Adverse Event
Injury
·PENUMBRA, INC.·Product code NRY·June 14, 2015
PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·June 26, 2015
PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·June 9, 2015
PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·September 9, 2015
PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·September 16, 2015
PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·July 30, 2015
PENUMBRA SYSTEM JETD REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·November 11, 2021
PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·October 16, 2015
PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·June 18, 2015
PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·June 25, 2015
PENUMBRA SYSTEM JETD REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·February 27, 2019
PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·June 17, 2015
PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·June 24, 2015
PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·September 25, 2015