373 results · 30ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Premier Resolution System

FDA 510(k)
FDA Class 2 ·Hematology

TORNIER INSITE FT BIOCOMPOSITE SUTURE ANCHOR

FDA 510(k)
FDA Class 2 ·Orthopedic

KUSKE BREAST APPLICATOR SET, MODEL 189.006

FDA 510(k)
FDA Class 2 ·Radiology

GRANUFLO

FDA Adverse Event
Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·October 31, 2014

IDC¿

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KRD·August 25, 2011

M2A-MAGNUM PF CUP 50ODX44ID

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWA·July 12, 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

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 14, 2025

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