55 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BrightMatter Guide with BrightMatter Pointer
FDA 510(k)
FDA Class 2
·Neurology
LEONE SPA
FDA UDI
LEONE SPA·08033707017745·CALIBRA 1ST MOLAR BANDS n.LR 23
ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENSOR MODEL HHS-SAFB-SM, HHS-SPFB-USA
FDA 510(k)
FDA Class 2
·Cardiovascular
NEUROPORT NEURAL SIGNAL PROCESSING SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
INDIGO SYSTEM ASPIRATION CATHETER 5
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·November 21, 2016
INDIGO SYSTEM ASPIRATION CATHETER D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·February 12, 2019
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
O3 PEDIATRIC SENSOR
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MUD·August 20, 2022
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
O3 PEDIATRIC SENSOR
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MUD·August 19, 2022
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