406 results · 24ms · Sources: EU EUDAMED, US FDA

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TorchTM Software

FDA 510(k)
FDA Class 2 ·Radiology

AZUR DETACHABLE 18

FDA 510(k)
FDA Class 2 ·Cardiovascular

ULTRASONIX ERGOSONIX 500 ULTRASOUND SCANNER

FDA 510(k)
FDA Class 2 ·Radiology

8800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 31, 2008

POLARIS ADJUSTABLE VALVE

FDA Adverse Event
Malfunction ·SOPHYSA·Product code JXG·July 15, 2011

IMPAX CV REPORTING

FDA Adverse Event
Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·July 8, 2013

3T HEATER/COOLER

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND·Product code DWC·March 19, 2026

HEATER-COOLER SYSTEM

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND·Product code DWC·October 1, 2025

MICROLET®

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code QRL·April 23, 2026

HEATER-COOLER SYSTEM

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND GMBH·Product code DWC·April 30, 2026

HEATER-COOLER SYSTEM 3T

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND GMBH·Product code DWC·October 10, 2025

HEATER COOLER 3T SYSTEM

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND·Product code DWC·December 3, 2025

HEATER-COOLER SYSTEM 3T

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND·Product code DWC·October 10, 2025

HEATER COOLER 3T SYSTEM

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND·Product code DTQ·April 22, 2026

HEATER COOLER 3T SYSTEM

FDA Adverse Event
Malfunction ·LIVANOVA DEUSTCHLAND·Product code DWC·April 7, 2026

HEATER-COOLER 3T SYSTEM

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND GMBH·Product code DWC·March 26, 2026

HEATER-COOLER 3T SYSTEM

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND GMBH·Product code DWC·February 10, 2026

HEATER-COOLER 3T SYSTEM

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND GMBH·Product code DWC·January 20, 2026

HEATER-COOLER SYSTEM 3T

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND GMBH·Product code DWC·January 23, 2026

HEATER COOLER 3T SYSTEM

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND·Product code DWC·April 16, 2026