Medical Device Manufacturer · US , Jacksonville , FL

Xomed-Treace, Inc. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 1991

12

Total

12

Cleared

0

Denied

FDA 510(k) Regulatory Record - Xomed-Treace, Inc. Ear, Nose, Throat ✕

10 devices

1-10 of 10

Cleared Mar 24, 1995

ENDOSCOPE SHEATH

Ear, Nose, Throat · 445d

Cleared Mar 14, 1995

TYMPANOSTOMY (VENTILATION) TUBE

Ear, Nose, Throat · 356d

Cleared Jan 09, 1995

BLACKSTAR(TM) STAR SYSTEM

Ear, Nose, Throat · 53d

Cleared Aug 24, 1994

BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE

Ear, Nose, Throat · 442d

Cleared Jul 18, 1994

XOMED-TREACE SCOPESHEATH

Ear, Nose, Throat · 355d

Cleared May 13, 1994

NERVE INTEGRITY MONITOR-2 (NIM-2 XL)

Ear, Nose, Throat · 245d

Cleared Jan 05, 1994

XOMED-TREACE RIGID ROD LENS ENDOSCOPE

Ear, Nose, Throat · 194d

Cleared Aug 17, 1993

XOMED-TREACE EMG ENDOTRACHEAL TUBEEN

Ear, Nose, Throat · 281d

Cleared Nov 09, 1992

XOMED-TREACE ALPHASCOPE

Ear, Nose, Throat · 101d

Cleared Apr 22, 1991

Ear, Nose, Throat · 115d