Xomed-Treace, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
12
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K940028ENDOSCOPE SHEATHMarch 24, 1995
K941407TYMPANOSTOMY (VENTILATION) TUBEMarch 14, 1995
K945659BLACKSTAR(TM) STAR SYSTEMJanuary 9, 1995
K932771BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCEAugust 24, 1994
K933672XOMED-TREACE SCOPESHEATHJuly 18, 1994
K934426NERVE INTEGRITY MONITOR-2 (NIM-2 XL)May 13, 1994
K933105XOMED-TREACE RIGID ROD LENS ENDOSCOPEJanuary 5, 1994
K925640XOMED-TREACE EMG ENDOTRACHEAL TUBEENAugust 17, 1993
K922880XOMED TREACE JET VENTILATION TUBEApril 15, 1993
K923830XOMED-TREACE ALPHASCOPENovember 9, 1992
K912753XOMED-TREACE POSITROL FOOTPEDAL SUCTION CONTROLSeptember 23, 1991
K905800X-T AIR DRILLApril 22, 1991