15 results · 31ms · Sources: EU EUDAMED, US FDA

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EPOC READER

FDA Adverse Event
Malfunction ·EPOCAL INC.·Product code CGL·January 25, 2021

T:FLEX INSULIN DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code LZG·December 26, 2020

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·June 29, 2023

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·March 21, 2023

T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·April 25, 2025

NON-HEATED ADULT BREATHING CIRCUIT

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZO·November 27, 2014

HEARTWARE® VENTRICULAR ASSIST SYSTEM

FDA Adverse Event
Death ·HEARTWARE, INC·Product code DSQ·February 29, 2016

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code OYC·May 20, 2013

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·September 26, 2014

COLLEUGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 10, 2011

TRULIANT KNEE COMPONENTS

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·July 14, 2025

VENTURE ANTERIOR CERVICAL PLATE SYSTEM

FDA Adverse Event
Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWQ·February 10, 2025

STYLE 15 SILICONE GEL FILLED BREAST IMPLANT

FDA Adverse Event
Injury ·ALLERGAN (COSTA RICA)·Product code FTR·October 9, 2020

HEARTWARE® VENTRICULAR ASSIST SYSTEM-CONTROLLER 2.0

FDA Adverse Event
Malfunction ·HEARTWARE, INC·Product code DSQ·October 24, 2017

TRULIANT TIB IMP PS INSERT SZ 1.5, 11MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·May 13, 2024