55 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARTLINE
FDA 510(k)
FDA Class 2
·Cardiovascular
LUMENIS ONE FAMILY OF SYSTEMS; LUMENIS ONE.
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ASCENSION MODULAR TOTAL SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PENUMBRA MAX PUMP - INDIGO SYSTEM
FDA Adverse Event
Malfunction
·PENUMBRA INC., USA·Product code NRY·August 23, 2018
INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·May 5, 2020
INSPIRE 8F M
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·January 3, 2024
PERMANENT CAUTERY SPATULA INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·June 10, 2013
SOFTCLIX ® LANCET DEVICE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·July 13, 2011
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·September 16, 2008
INSPIRE 8F M
FDA Adverse Event
Injury
·SORIN GROUP ITALIA·Product code DTZ·January 4, 2024
PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·March 8, 2018
INSPIRE OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·March 12, 2026
INSPIRE OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·March 12, 2026
PENUMBRA SYSTEM ASPIRATION PUMP MAX 220
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·April 9, 2018
INSPIRE 8F
FDA Adverse Event
Injury
·SORIN GROUP ITALIA·Product code DTZ·November 5, 2025
INSPIRE 8F
FDA Adverse Event
Injury
·SORIN GROUP ITALIA·Product code DTZ·November 5, 2025
INSPIRE OXYGENATOR
FDA Adverse Event
Injury
·SORIN GROUP ITALIA·Product code DTZ·December 11, 2025
INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·April 20, 2021
INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·September 11, 2020
INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·December 23, 2020