23 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
FDA 510(k)
FDA Class 2
·Cardiovascular
Bioplate®
FDA UDI
Bioplate, Inc.·M384K248500·Maxfax Set Basic
MEDALLION MODULAR HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
FLOSPINE PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 9, 2011
STERRAD 100S STERILIZER
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·November 10, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code ITI·July 22, 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