27 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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qXR-CTR
FDA 510(k)
FDA Class 2
·Radiology
Unity Total Knee System
FDA UDI
CORIN LTD·05056139232572·Distal Resection Guide
BD BBL™ Sensi-Disc™ Nitrofurantoin 300 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·00382902311492·BD BBL™ Sensi-Disc™ Nitrofurantoin 300 µg
Sklar®
FDA UDI
SKLAR CORPORATION·10649111146305·SKLIT IRIS SCISS STR S/S 4 1/2
OLYMPIC CFM 6000
FDA 510(k)
FDA Class 2
·Neurology
CoLink Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·November 7, 2025
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·January 9, 2026
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·January 9, 2026
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·May 23, 2025
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·March 25, 2026
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·October 28, 2025
LYNX ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·December 12, 2025
LYNX ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·September 4, 2025
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code PEA·June 14, 2024
GLIDEWELL HT IMPLANT Ø4.3 X 8 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·November 25, 2025
GLIDEWELL HT IMPLANT Ø4.3 X 8 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·December 3, 2025
GLIDEWELL HT IMPLANT Ø5.0 X 10 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·May 13, 2025
GLIDEWELL HT IMPLANT Ø4.3 X 8 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC·Product code DZE·April 4, 2025
GLIDEWELL HT IMPLANT Ø4.3 X 8 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·January 29, 2026