229 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Perfadex Plus
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HUMERAL NAIL
FDA UDI
Biomet Orthopedics, LLC·00887868004940·
SILICONE MCP
FDA UDI
Stryker GmbH·00886385021874·Metacarpal Broach, Size 50
PENUMBRA CATHERER 025
FDA 510(k)
FDA Class 2
·Cardiovascular
KD-795 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
COMFORT TOUCH INSUIN PEN NEEDLES
FDA Adverse Event
Malfunction
·JIANGSU CAINA TECHNOLOGY CO., LTD.·Product code FMI·May 21, 2021
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
GMK SPHERE IMPLANTS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 4, 2025
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 6, 2013
HEARTSTART MRX - EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·June 22, 2011
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·September 15, 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
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 21, 2025