327 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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REPROCESSED SOFT TISSUE ABLATORS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04047872673174·LEVAMED STABILI-TRI ANK BLU R I
Zirlux
FDA UDI
HENRY SCHEIN, INC.·00304040133286·Zirlux TR A4 98x22mm
Omnilink Elite
FDA UDI
ABBOTT VASCULAR INC.·08717648178528·Omnilink Elite Vascular Balloon-Expandable Sten...
Omnilink Elite
FDA UDI
ABBOTT VASCULAR INC.·08717648178498·Omnilink Elite Vascular Balloon-Expandable Sten...
Omnilink Elite
FDA UDI
ABBOTT VASCULAR INC.·08717648178511·Omnilink Elite Vascular Balloon-Expandable Sten...
Omnilink Elite
FDA UDI
ABBOTT VASCULAR INC.·08717648178504·Omnilink Elite Vascular Balloon-Expandable Sten...
Kalitec Disc Prep
FDA UDI
Kalitec Direct LLC·B07319K0162310·Bone Funnel, Wedged
NEMIO
FDA 510(k)
FDA Class 2
·Radiology
ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG
FDA 510(k)
FDA Class 2
·Neurology
GLIDEWELL HT IMPLANT
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·September 30, 2025
DISPOSABLE LAPCLINCH GRASPER TIP
FDA Adverse Event
Other
·MICROLINE SURGICAL INC.·Product code GEI·March 15, 2013
PROXIMATE** SKIN STAPLER 35 WIDE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDT·March 10, 2011
IDC-INTERLOCKING DETACHABLE COIL
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORK LTD·Product code HCG·March 10, 2008
Cronus-1 Endovascular Guidewire, Length 210 cm (full coat), Diameter 0.014 inch, Part Number 001-001263-1
FDA Recall
Terminated
·Stereotaxis Inc·Product code NFN·January 27, 2004
INSET II
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·December 4, 2025
INSET II
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·December 4, 2025
INSET II
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·December 4, 2025
INSET II
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·December 4, 2025
GLIDEWELL HT IMPLANT Ø4.3 X 10 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 10, 2024