230 results · 40ms · Sources: EU EUDAMED, US FDA

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NXSTAGE SYSTEM ONE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE

FDA 510(k)
FDA Class 3 ·Cardiovascular

GMK-SPHERE 02.07.1204R TIBIAL TRAY FIXED CEMENTED SIZE 4 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 2, 2023

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 29, 2019

ONE TOUCH ULTRA

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code CFR·May 5, 2003

GMK SPHERE IMPLANTS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 4, 2025

ASR ACETABULAR IMPLANT 50

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·May 31, 2013

ALARIS PUMP MODULE ADMINISTRATION SET

FDA Adverse Event
Malfunction ·CAREFUSION CORP.·Product code FPA·June 15, 2011

COAGUCHEK XS SYSTEM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·August 28, 2008

GMK-SPHERE 02.07.1206L TIBIAL TRAY FIXED CEMENTED SIZE 6 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 20, 2022

GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R

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

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

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 30, 2019

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 30, 2022

GMK PRIMARY TOTAL KNEE SYSTEM

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

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 7, 2023

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 17, 2025

O3 PEDIATRIC SENSOR

FDA Adverse Event
Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MUD·August 20, 2022

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 21, 2025

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 9, 2022