10,000 results
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65ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SPECTRUM IQI NFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 19, 2021
DREAMSTATION AUTO CPAP
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·August 18, 2022
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 16, 2015
MOBI
FDA Adverse Event
Injury
·TANDEM DIABETES CARE, INC.·Product code QFG·December 2, 2025
ONE TOUCH VERIO IQ BG METER
FDA Adverse Event
Malfunction
·LIFESCAN·Product code NBW·June 2, 2015
TANDEM T:SLIM X2
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE, INC.·Product code QFG·April 26, 2024
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 23, 2013
OT VERIO IQ METER
FDA Adverse Event
LIFESCAN INC.·Product code NBW·May 23, 2013
CONTINUOUS GLUCOSE MONITOR
FDA Adverse Event
Injury
·DEXCOM, INC.·Product code QBJ·June 17, 2025
TANDEM INSULIN PUMP WITH CONTROL IQ
FDA Adverse Event
Injury
·TANDEM DIABETES CARE, INC.·Product code LZG·June 22, 2020
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code QFG·April 12, 2023
TANDEM TSLIM X2
FDA Adverse Event
Injury
·TANDEM DIABETES CARE, INC.·Product code QFG·October 14, 2025
TANDEM TSLIM X2
FDA Adverse Event
Injury
·TANDEM DIABETES CARE, INC.·Product code QFG·October 14, 2025
TANDEM TSLIM X2
FDA Adverse Event
Injury
·TANDEM DIABETES CARE, INC.·Product code QFG·October 14, 2025
TANDEM TSLIM X2
FDA Adverse Event
Injury
·TANDEM DIABETES CARE, INC.·Product code QFG·October 14, 2025
TANDEM TSLIM X2
FDA Adverse Event
Injury
·TANDEM DIABETES CARE, INC.·Product code QFG·October 14, 2025
TANDEM TSLIM X2
FDA Adverse Event
Injury
·TANDEM DIABETES CARE, INC.·Product code QFG·October 14, 2025
DEXCOM G6 CONTINUOUS GLUCOSE MONITOR
FDA Adverse Event
Malfunction
·DEXCOM INC·Product code QBJ·January 15, 2021
ECT
FDA Adverse Event
Injury
·Product code GXC·August 10, 2007
Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a segmentation measurement tool REF/Model: 850-20003 Software versions 1.13.0, 1.14.0, and 1.15.0 - Product Usage: Butterfly iQ is indicated for use by qualified and trained healthcare professionals to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients.
FDA Enforcement
Class II
·Terminated·Butterfly Network, Inc.·April 8, 2020