32 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Leksell Gamma Knife Icon
FDA 510(k)
FDA Class 2
·Radiology
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FDA 510(k)
FDA Class 2
·Dental
CODONICS HORIZON XL DIGITAL DIRECT LONG FILM IMAGER; CODONICS HORIZON XL-X LONG FILM IMAGER
FDA 510(k)
FDA Class 2
·Radiology
Widex
FDA UDI
Widex A/S·05706069889420·WIDEX MOMENT M-CIC TR (Light beige ) 440, Left
Widex
FDA UDI
Widex A/S·05706069560411·Widex UNIQUE U-CIC TR (Dark brown ) 440, Left, ...
Widex
FDA UDI
Widex A/S·05706069560404·Widex UNIQUE U-CIC TR (Clay brown ) 440, Left, ...
Widex
FDA UDI
Widex A/S·05706069889437·WIDEX MOMENT M-CIC TR (Clay brown ) 440, Left
Widex
FDA UDI
Widex A/S·05706069889444·WIDEX MOMENT M-CIC TR (Dark brown ) 440, Left
Widex
FDA UDI
Widex A/S·05706069560398·Widex UNIQUE U-CIC TR (Light beige ) 440, Left,...
PENUMBRA MAX PUMP - INDIGO SYSTEM
FDA Adverse Event
Malfunction
·PENUMBRA INC., USA·Product code NRY·August 23, 2018
PLEURX LOCKABLE DRAINAGE LINE SET
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·April 2, 2026
PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·March 8, 2018
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·October 10, 2014
CAPSUREFIX MRI SURESCAN
FDA Adverse Event
Injury
·MPRI·Product code NVN·June 10, 2013
BASIX COMPAK INFLATION SYRINGE
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DXT·June 20, 2011
CONTOUR® PLUS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·February 20, 2025
PENUMBRA SYSTEM ASPIRATION PUMP MAX 220
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·April 9, 2018
PLEURX DRAINAGE KIT 500ML 10/CS
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·July 25, 2025
PLEURX
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·September 26, 2025
PLEURX DRAINAGE KIT 1000ML
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·January 20, 2026