15 results · 21ms · Sources: EU EUDAMED, US FDA

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Intrisound™ Tuned Lumen® 155 Hearing Aids

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64:

FDA 510(k)
FDA Class 2 ·Radiology

Medical nitrile examination gloves (Model: JL001)

FDA 510(k)
FDA Class 1 ·General Hospital

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·September 4, 2024

GMK SPHERE CEMENTLESS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·May 25, 2026

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 21, 2024

GMK 3D METAL TIBIAL TRAY

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 12, 2025

GMK SPHERIKA CEMENTLESS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·March 16, 2026

SYNCHROMED II

FDA Adverse Event
Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·November 4, 2014

PENUMBRA SYSTEM REPERFUSION CATHETER 054

FDA Adverse Event
Injury ·PENUMBRA INC.·Product code NRY·August 18, 2011

APEX KNEE SYSTEM

FDA Adverse Event
Injury ·OMNLIFE SCIENCE, INC·Product code JWH·July 10, 2013

GMK SPHERIKA CEMENTLESS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·December 19, 2025

GMK SPHERIKA CEMENTLESS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·December 24, 2025

GMK 3D METAL TIBIAL TRAY

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 11, 2025

GMK 3D METAL TIBIAL TRAY

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 29, 2025