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