466 results · 23ms · Sources: EU EUDAMED, US FDA

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DISPOSABLE BLOOD PRESSURE TRANSDUCER

FDA 510(k)
FDA Class 2 ·Cardiovascular

STERLING

FDA UDI
BENCO DENTAL SUPPLY CO.·00366975064257·

GMK SPHERE

FDA 510(k)
FDA Class 2 ·Orthopedic

AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL

FDA 510(k)
FDA Class 2 ·Dental

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 23, 2025

GMK-SPHERE PATELLA RESURFACING SIZE 2

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 25, 2024

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T4-I3 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 14, 2019

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code JWH·November 21, 2025

GMK SPHERE FEMORAL COMPONENT SIZE 4 LEFT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 3, 2016

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 22, 2021

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 10, 2021

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 2, 2025

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 30, 2026

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 26, 2019

E SERIES DEFIBRILLATOR

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·April 25, 2014

OXFORD PKS MEN BEARING UHMWPE SMALL SZ 4

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code NRA·November 6, 2012

LIFEVEST WCD 3000 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL LIFECOR CORP·Product code MVK·August 25, 2010

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 21, 2022

GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 8, 2021

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 18, 2023