28 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACDF STAND ALONE CERVICAL
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVE·October 8, 2025
Mecta-C Stand Alone
FDA 510(k)
FDA Class 2
·Orthopedic
ACDF STAND ALONE CERVICAL
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVE·April 25, 2025
ACDF STAND ALONE CERVICAL
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVE·December 22, 2025
ACDF 03.18.118 MECTA-C SA TIPEEK CAGE 18X15X6X7°
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVE·May 12, 2023
ACDF STAND ALONE CERVICAL
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OVE·June 13, 2025
VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION
FDA 510(k)
FDA Class 2
·General Hospital
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code FDX·February 22, 2021
DAMON COPPER NITI WIRE
FDA Adverse Event
Malfunction
·ORMCO CORPORATION·Product code DZC·October 10, 2008
ECHELON*FLEX60
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 27, 2013
PENUMBRA SYSTEM SEPARATOR 032
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·July 25, 2011
Quanta System Sterile Optical Laser Fiber, single use
FDA Enforcement
Class II
·Terminated·Quanta System, S.p.A.·June 16, 2021
FUSION CYTOLOGY BRUSH
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code FDX·January 6, 2022
FUSION CYTOLOGY BRUSH
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code FDX·October 25, 2021
CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH
FDA Adverse Event
Injury
·WILSON-COOK MEDICAL INC·Product code FDX·May 4, 2022
CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH
FDA Adverse Event
Injury
·WILSON-COOK MEDICAL INC·Product code FDX·November 14, 2022
CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code FDX·August 27, 2024
FUSION CYTOLOGY BRUSH
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code FDX·July 31, 2024
CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code FDX·May 28, 2024