Medical Device Manufacturer · US , North Attleboro , MA

Sodemsystems - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1994

Recent clearances: SODEM PERFORATOR DRIVE, MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sodemsystems Ear, Nose, Throat ✕

2 devices

1-2 of 2

Cleared Jan 28, 2003

SODEM HIGH SPEED SYSTEM (PNEUMATIC)

Ear, Nose, Throat · 134d

Cleared Sep 21, 2001

SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)

Ear, Nose, Throat · 51d