17 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Zfx Abutments
FDA 510(k)
FDA Class 2
·Dental
PULPDENT ETCH-RITE ROYALE
FDA 510(k)
FDA Class 2
·Dental
GenesisZr 4Y+ (ST1100) Zirconia
FDA 510(k)
FDA Class 2
·Dental
XMAX MOTOR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code ERL·November 6, 2014
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·September 1, 2011
URETEX SUPPORT PP KIT X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code OTN·July 11, 2013
Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·February 14, 2024
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·April 14, 2026
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·March 3, 2026
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·November 10, 2025
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·April 23, 2025
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·May 13, 2025
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·April 29, 2025
EQUINOXE REVERSE SHOULDER COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 9, 2026
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·February 26, 2026
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·February 26, 2026
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·January 10, 2025