24 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SMITH & NEPHEW RADIOPAQUE TRIAL NECKS
FDA 510(k)
FDA Class 2
·Orthopedic
UCR
FDA UDI
Seaspine Orthopedics Corporation·10889981029302·CROSSBAR, XSMALL, 6.35 ROD
INION CPS 2.0 ORTHOGNATHIC PLATE
FDA 510(k)
FDA Class 2
·Dental
BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·September 13, 2019
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·February 6, 2019
INTELLIVUE MP2
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·May 25, 2011
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·May 9, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 24, 2014
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·November 3, 2021
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·July 29, 2019
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·December 26, 2019
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 4, 2020
U BY KOTEX SLEEK
FDA Adverse Event
Malfunction
·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·August 31, 2018
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·May 31, 2019
U BY KOTEX SLEEK
FDA Adverse Event
Malfunction
·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·June 27, 2018
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·April 7, 2021
BD ULTRA-FINE II INSULIN SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·April 6, 2020
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·November 30, 2021
EQUINOXE ANATOMIC SHOULDER COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWS·May 22, 2025