Medical Device Manufacturer · US , North Attleboro , MA

Sodemsystems - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1994

8

Total

8

Cleared

0

Denied

Sodemsystems has 8 FDA 510(k) cleared medical devices. Based in North Attleboro, US.

Historical record: 8 cleared submissions from 1994 to 2003. Primary specialty: Neurology.

Browse the FDA 510(k) cleared devices submitted by Sodemsystems Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Sodemsystems

8 devices

1-8 of 8

Cleared Jan 28, 2003

SODEM HIGH SPEED SYSTEM (PNEUMATIC)

Ear, Nose, Throat · 134d

Cleared Nov 25, 2002

DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC)

Neurology · 70d

Cleared Oct 22, 2001

SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY)

Neurology · 82d

Cleared Oct 22, 2001

SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY)

Neurology · 82d

Cleared Sep 21, 2001

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

Ear, Nose, Throat · 51d

Cleared Dec 27, 1999

SODEM PERFORATOR DRIVE

Neurology · 45d

Cleared Dec 21, 1999

MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE

Neurology · 11d

Cleared Jan 21, 1994

SODEM POWER SYSTEM

Orthopedic · 64d