38 results · 36ms · Sources: EU EUDAMED, 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