Medical Device Manufacturer · US , Jacksonville , FL

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

12 submissions · 12 cleared · Since 1991

Total

Cleared

Denied

Xomed-Treace, Inc. has 12 FDA 510(k) cleared ear, nose, throat devices. Based in Jacksonville, US.

Historical record: 12 cleared submissions from 1991 to 1995.

Browse the complete list of FDA 510(k) cleared ear, nose, throat devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Xomed-Treace, Inc.

12 devices

1-12 of 12

Cleared Mar 24, 1995

ENDOSCOPE SHEATH

K940028 · EOB

Ear, Nose, Throat · 445d

Cleared Mar 14, 1995

TYMPANOSTOMY (VENTILATION) TUBE

K941407 · ETD

Ear, Nose, Throat · 356d

Cleared Jan 09, 1995

BLACKSTAR(TM) STAR SYSTEM

K945659 · ERL

Ear, Nose, Throat · 53d

Cleared Aug 24, 1994

BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE

K932771 · EQH

Ear, Nose, Throat · 442d

Cleared Jul 18, 1994

XOMED-TREACE SCOPESHEATH

K933672 · EOB

Ear, Nose, Throat · 355d

Cleared May 13, 1994

NERVE INTEGRITY MONITOR-2 (NIM-2 XL)

K934426 · ETN

Ear, Nose, Throat · 245d

Cleared Jan 05, 1994

XOMED-TREACE RIGID ROD LENS ENDOSCOPE

K933105 · EOB

Ear, Nose, Throat · 194d

Cleared Aug 17, 1993

XOMED-TREACE EMG ENDOTRACHEAL TUBEEN

K925640 · ETN

Ear, Nose, Throat · 281d

Cleared Apr 15, 1993

XOMED TREACE JET VENTILATION TUBE

K922880 · BTR

Anesthesiology · 304d

Cleared Nov 09, 1992

XOMED-TREACE ALPHASCOPE

K923830 · ERA

Ear, Nose, Throat · 101d

Cleared Sep 23, 1991

XOMED-TREACE POSITROL FOOTPEDAL SUCTION CONTROL

K912753 · GCX

General Hospital · 91d

Cleared Apr 22, 1991

X-T AIR DRILL

K905800 · ERL

Ear, Nose, Throat · 115d

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

Filters