38 results
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36ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EdgeOne CO2 Laser
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
APPLIED LAPAROSCOPIC DISPOSABLE MONOPOLAR SCISSORS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CYBERWAND LITHOTRIPTER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·September 20, 2019
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·September 12, 2019
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·September 24, 2022
ZILVER 518 BILIARY SELF-EXPANDING STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·September 21, 2017
ZILVER 635 BILIARY SELF-EXPANDING STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·September 20, 2017
ZILVER 635 SELF-EXPANDING BILIARY STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·September 7, 2017
ZILVER 635 SELF-EXPANDING BILIARY STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·February 28, 2018
ZILVER 635 BILIARY SELF-EXPANDING STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·February 12, 2018
M2A-MAGNUM PF CUP 50ODX44ID
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·June 11, 2013
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Injury
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·July 7, 2011
PRECISION XTRA /OPTIUM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code NBW·September 15, 2008
PROAQT SENSOR
FDA Adverse Event
Malfunction
·PULSION MEDICAL SYSTEMS SE·Product code DXG·August 18, 2025
ZILVER 518 BILIARY SELF-EXPANDING STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·February 14, 2017
ZILVER 635 BILIARY SELF-EXPANDING STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·January 4, 2018
ZILVER 635 SELF-EXPANDING BILIARY STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·April 5, 2017
ZILVER 635 SELF-EXPANDING BILIARY STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·July 3, 2017
ZILVER 635 SELF-EXPANDING BILIARY STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·June 13, 2017