MIM – Y90 Dosimetry

FDA 510(k)

FDA Class 2 ·Radiology

MIM 5.2 (BRACHY)

FDA 510(k)

FDA Class 2 ·Radiology

MIM - MRT Dosimetry

FDA 510(k)

FDA Class 2 ·Radiology

MIM – Additional Tracers

FDA 510(k)

FDA Class 2 ·Radiology

MIM - SPECTRA Quant

FDA 510(k)

FDA Class 2 ·Radiology

MIM 4.0 (NEURO

FDA 510(k)

FDA Class 2 ·Radiology

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·EPIC/+/II, ATLAS/+/II, CURRENT/CURRENT+ AND PROMOTE+ FAMILY OF DEVICES

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·EPIC/+/II, ATLAS/+/II, CURRENT/CURRENT+ AND PROMOTE+ FAMILY OF DEVICES

Widex

FDA UDI

Widex A/S·05706069952551·WIDEX MAGNIFY M-IM (Dark brown)

Widex

FDA UDI

Widex A/S·05706069887532·WIDEX MOMENT M-IM (Light beige ) 330, Right

Widex

FDA UDI

Widex A/S·05706069887518·WIDEX MOMENT M-IM (Clay brown ) 220, Right

Widex

FDA UDI

Widex A/S·05706069887389·WIDEX MOMENT M-IM (Light beige ) Right

Widex

FDA UDI

Widex A/S·05706069887549·WIDEX MOMENT M-IM (Clay brown ) 330, Right

Widex

FDA UDI

Widex A/S·05706069887686·WIDEX MOMENT M-IM (Light beige ) 110, Left

Widex

FDA UDI

Widex A/S·05706069887785·WIDEX MOMENT M-IM (Clay brown ) 440, Left

Widex

FDA UDI

Widex A/S·05706069887716·WIDEX MOMENT M-IM (Light beige ) 220, Left

Widex

FDA UDI

Widex A/S·05706069887600·WIDEX MOMENT M-IM (Clay brown ) Left

Widex

FDA UDI

Widex A/S·05706069887402·WIDEX MOMENT M-IM (Dark brown ) Right

Widex

FDA UDI

Widex A/S·05706069887396·WIDEX MOMENT M-IM (Clay brown ) Right

Widex

FDA UDI

Widex A/S·05706069952407·WIDEX MAGNIFY M-IM (Dark brown)