Medical Device Manufacturer · US , Charlotte , NC

Simbionix , Ltd. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2010

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Simbionix , Ltd. Radiology ✕

3 devices

1-3 of 3

Cleared Jan 29, 2013

PROCEDURE REHEARSAL STUDIO

Radiology · 102d

Cleared Dec 27, 2011

PROCEDURE REHEARSAL STUDIO(TM)

Radiology · 131d

Cleared Aug 20, 2010

PROCEDURE REHEARSAL STUDIO

Radiology · 305d