8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ORTHOLOC ADVANTIM REVISION FEMORAL COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
FUJIFILM 600 SERIES ENDOSCOPES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FUJIFILM 600 SERIES ENDOSCOPE EC-600WM
FDA Adverse Event
Malfunction
·FUJIFILM CORPORATION·Product code FDF·January 22, 2025
MONARC SLING SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code OTN·January 25, 2013
MERIT CUSTOM KIT
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·December 14, 2010
EMAX 2 PLUS MOTOR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 14, 2014
BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020