37 results
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34ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ESAOTE S.P.A.
FDA registration
ESAOTE S.P.A.·4 products·🇮🇹 Italy
ESAOTE S.P.A.
FDA registration
ESAOTE S.P.A.·2 products·🇮🇹 Italy
ESAOTE S.P.A.
FDA registration
ESAOTE S.P.A.·4 products·🇮🇹 Italy
ARTOSCAN
FDA Adverse Event
Death
·ESAOTE S.P.A.·Product code LNH·May 25, 2001
ARTOSCAN
FDA Adverse Event
Death
·ESAOTE S.P.A.·Product code LNH·December 22, 2000
ECG SYSTEMS
FDA Adverse Event
Malfunction
·ESAOTE S.P.A.·Product code DRT·December 30, 2003
C-SCAN
FDA Adverse Event
Other
·ESAOTE S.P.A.·Product code LNH·December 23, 2003
MYL
FDA Adverse Event
Malfunction
·ESAOTE S.P.A.·Product code IYN·May 4, 2005
ECG SYSTEMS
FDA Adverse Event
Malfunction
·ESAOTE S.P.A.·Product code DRT·May 3, 2004
ECG SYSTEMS
FDA Adverse Event
Malfunction
·ESAOTE S.P.A.·Product code DRT·May 3, 2004
ECG SYSTEMS
FDA Adverse Event
Malfunction
·ESAOTE, S.P.A.·Product code DRT·May 3, 2004
ECG SYSTEMS
FDA Adverse Event
Malfunction
·ESAOTE, S.P.A.·Product code DRT·May 3, 2004
ECG SYSTEMS
FDA Adverse Event
Malfunction
·ESAOTE, S.P.A.·Product code DRT·May 3, 2004
ESCAN XQ
FDA Adverse Event
Injury
·ESAOTE S.P.A.·Product code LNH·May 23, 2008
ESAOTE
FDA Adverse Event
Malfunction
·ESAOTE S.P.A.·Product code IYN·December 20, 2013
Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
FDA Enforcement
Class II
·Completed·ESAOTE S.P.A.·March 11, 2026
Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000)
FDA Enforcement
Class II
·Terminated·Esaote S.p.A.·July 13, 2016
MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; Probes: BL433, C 18, CA541, EC1123, EC123, IH 618, IOT332, IOT342, L 415, LA332E, LA435, LA523, LA533, SI2C41, SL2325, TRT33
FDA Enforcement
Class II
·Terminated·ESAOTE S.P.A.·March 28, 2018
MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/10
FDA Enforcement
Class II
·Terminated·ESAOTE S.P.A.·March 28, 2018
MyLab Seven, Model 6400
FDA Enforcement
Class II
·Terminated·ESAOTE S.P.A.·October 31, 2018