Medical Device Manufacturer · US , Burlington , MA

Radionics, A Division of Tyco Healthcare Group LP - FDA 510(k) Cleare...

8 submissions · 8 cleared · Since 2001

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Radionics, A Division of Tyco Healthcare Group LP Neurology ✕

4 devices

1-4 of 4

Cleared Sep 15, 2003

RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE

Neurology · 75d

Cleared Sep 11, 2002

RADIONICS POLE NEEDLES

Neurology · 90d

Cleared Nov 19, 2001

RECORDING AND STIMULATING ELECTRODE

Neurology · 87d

Cleared Mar 12, 2001

MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)

Neurology · 14d