Xomed, Inc. - FDA 510(k) Cleared Devices
82
Total
81
Cleared
0
Denied
82 devices
Cleared
May 02, 1997
XOMED SILICONE BLOCK/STRIP
Ear, Nose, Throat
51d
Cleared
Apr 04, 1997
SHARPSITE AC
Ear, Nose, Throat
94d
Cleared
Mar 10, 1997
ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS
Ear, Nose, Throat
91d
Cleared
Jan 24, 1997
KARTUSH TM PATCHER
Ear, Nose, Throat
78d
Cleared
Jul 01, 1996
ACTIVENT ANTIMICROBIAL VENTILATION TUBES
Ear, Nose, Throat
47d
Cleared
Apr 03, 1996
ACE SYSTEM
Ear, Nose, Throat
33d
Cleared
Aug 29, 1990
LASER-SHIELD II(TM)
General & Plastic Surgery
177d
Cleared
Mar 22, 1989
FLEXIBLE ENDOSCOPE 91-8200(90) AND 91-82100(135)
Ear, Nose, Throat
135d
Cleared
Feb 15, 1989
XOMED IONESTHETIZER(TM)
Physical Medicine
89d
Cleared
Nov 30, 1988
MODIFIED IMPLANT FOR XOMED AUDIANT BONE CONDUCTOR
Ear, Nose, Throat
65d
Cleared
Sep 13, 1988
PUNCH MYRINGOTOMY SYSTEM
Ear, Nose, Throat
75d
Cleared
Jun 21, 1988
XOMED AUDIANT BONE CONDUCTOR
Ear, Nose, Throat
81d
Cleared
Mar 14, 1988
ADDITIONAL INDICATIONS FOR XOMED AUDIANT BONE CON.
Ear, Nose, Throat
81d
Cleared
Jul 02, 1987
XOMED PLATINUM WIRE TEFLON PISTION
Ear, Nose, Throat
31d
Cleared
Jun 30, 1987
XOMED AUDIANT BONE CONDUCTOR AT THE EAR SOUND PRO.
Ear, Nose, Throat
22d
Cleared
May 30, 1986
XOMED AUDIANT BONE CONDUCTOR W/IMPROVED AA COIL
Ear, Nose, Throat
9d
Cleared
Apr 03, 1986
AUDIANT BONE CONDUCTOR OR A.B.C.
Ear, Nose, Throat
106d
Cleared
Mar 28, 1986
OSTEO-MESH CRANIAL FAIRING
General & Plastic Surgery
46d
Cleared
Jan 06, 1986
GOODE T-TUBE WHITE SILICONE TYMPANOSTOMY TUBE
Ear, Nose, Throat
215d
Cleared
Jan 06, 1986
GODDE T-TUBE BLUE SILICONE TYMPANOSTOMY TUBE
Ear, Nose, Throat
125d
Cleared
Sep 12, 1983
RECTAL TEMP. TELEMETRY MONITOR
General Hospital
54d
Cleared
Jul 28, 1983
INTRA-ORAL ARTIFICIAL LARYNX
Ear, Nose, Throat
113d
Cleared
Oct 22, 1982
MICRO-CRAFT OSCILLATING SAW HANDPIECE
Orthopedic
37d
Cleared
Jul 26, 1982
XOMED MANDIBULAR TRAY
Ear, Nose, Throat
28d
Cleared
Jul 08, 1982
XOMED PATENCY MONITOR
Cardiovascular
59d
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