101 results
·
22ms
·
Sources: EU EUDAMED, US FDA
FilmArray RP EZ Control Panel M265
FDA 510(k)
FDA Class 2
·Microbiology
SURGISTAR
FDA UDI
SURGISTAR, INC.·00878799007469·
ACCUSCULPT II LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
INDIGO SYSTEM ASPIRATION CATHETER D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·February 12, 2019
INDIGO SYSTEM SEPARATOR D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·April 18, 2018
INDIGO SYSTEM CATD ASPIRATION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·May 29, 2019
INDIGO SYSTEM CATD ASPIRATION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·January 17, 2020
INDIGO SYSTEM ASPIRATION CATHETER D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·December 7, 2018
INDIGO SYSTEM ASPIRATION CATHETER D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code QEW·January 29, 2021
INDIGO SYSTEM ASPIRATION CATHETER D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·December 10, 2020
PENUMBRA SYSTEM JETD REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·June 5, 2019
INDIGO SYSTEM CATD ASPIRATION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·January 25, 2019
INDIGO SYSTEM CATD ASPIRATION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·January 25, 2019
INDIGO SYSTEM CATD ASPIRATION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·July 28, 2020
INDIGO SYSTEM ASPIRATION CATHETER D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·July 29, 2020
INDIGO SYSTEM CATD ASPIRATION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·September 11, 2020
INDIGO SYSTEM CATD ASPIRATION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·September 24, 2019
NOVASURE IMPEDANCE CONTROLLED EA SYSTEM
FDA Adverse Event
Injury
·HOLOGIC·Product code MNB·May 6, 2013
FLEXTEND
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 14, 2011