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

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AccurSound Electronic Stethoscope AS-101

FDA 510(k)
FDA Class 2 ·Cardiovascular

SEAL & PROTECT PROTECTIVE SEALANT

FDA 510(k)
FDA Class 2 ·Dental

AMS LARGE PORE POLYPROPHLENE MESH

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

DIMENSION CLINICAL CHEMISTRY SYSTEM

FDA Adverse Event
Other ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code DHA·November 3, 2008

LIFEPAK CR PLUS DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·August 17, 2011

INFINITI VISION SYSTEM OZIL

FDA Adverse Event
Injury ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·July 9, 2013

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 SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 5, 2025

GMK 3D METAL TIBIAL TRAY

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 6, 2025

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 MBH·January 23, 2026

GMK 3D METAL TIBIAL TRAY

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

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 19, 2024

GMK SPHERIKA CEMENTLESS

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

GMK 3D METAL TIBIAL TRAY

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

GMK TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 26, 2025

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code JWH·April 15, 2026

GMK 3D METAL TIBIAL TRAY

FDA Adverse Event
Death ·MEDACTA INTERNATIONAL SA·Product code JWH·January 19, 2026