Sodemsystems

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
8
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K023070SODEM HIGH SPEED SYSTEM (PNEUMATIC)January 28, 2003
K023066DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC)November 25, 2002
K012453SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY)October 22, 2001
K012457SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY)October 22, 2001
K012456SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)September 21, 2001
K993851SODEM PERFORATOR DRIVEDecember 27, 1999
K994175MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USEDecember 21, 1999
K935567SODEM POWER SYSTEMJanuary 21, 1994