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Xomed, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
82
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K002395MODEL 30 CLASSIC PNEUMATONOMETERDecember 11, 2000
K002987REDTRONIC XOMED MONOPOLAR ENERGIZED BLADEDecember 4, 2000
K002828XPS NITRO SYSTEMOctober 17, 2000
K002897TITANIUM MIDDLE EAR PROSTHESESOctober 11, 2000
K993653MICRO-FRANCE TROCARS AND ACCESSORIESJune 9, 2000
K001148MEROGEL OTOLOGIC PACKJune 3, 2000
K994262FRONTAL SINUS TREPHINATION CANNULAFebruary 8, 2000
K992855XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPTJanuary 21, 2000
K993582MODIFICATION TO LASER-SHIELD IIJanuary 20, 2000
K993655MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUSDecember 21, 1999
K993112XOMED ENT RF SYSTEMDecember 9, 1999
K992869XOMED BALL-TIP MONOPOLAR STIMULATOR PROBEOctober 7, 1999
K992282MICRO-FRANCE LIPOSUCTION CANNULASSeptember 23, 1999
K984363XPS TISSUE ASPIRATION SYSTEM, XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEMFebruary 26, 1999
K982731MEROGEL NASAL DRESSING AND SINUS STENTFebruary 2, 1999
K983025XOMED FEATHERTOUCH XPS POWER RASP ATTACHMENTNovember 6, 1998
K982870EPIFILM OTOLOGIC LAMINANovember 3, 1998
K983224XPS DRILL SYSTEMOctober 21, 1998
K982294XOMED SILICONE PRE-FORM BLOCKSSeptember 18, 1998
K982595NIM4September 4, 1998