FDA 510(k) Applications Submitted by XOMED, INC.
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K001148 |
04/10/2000 |
MEROGEL OTOLOGIC PACK |
XOMED, INC. |
K970910 |
03/12/1997 |
XOMED SILICONE BLOCK/STRIP |
XOMED, INC. |
K971124 |
03/27/1997 |
TM MICRO-CATHETERS |
XOMED, INC. |
K961873 |
05/15/1996 |
ACTIVENT ANTIMICROBIAL VENTILATION TUBES |
XOMED, INC. |
K972453 |
06/30/1997 |
XPS STRAIGHTSHOT MICRORESECTOR |
XOMED, INC. |
K982595 |
07/27/1998 |
NIM4 |
XOMED, INC. |
K992855 |
08/24/1999 |
XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT |
XOMED, INC. |
K983224 |
09/14/1998 |
XPS DRILL SYSTEM |
XOMED, INC. |
K973499 |
09/16/1997 |
XPS STRAIGHTSHOT MICROBRIDER SYSTEM OR TREBAY SHAVER SYSTEM |
XOMED, INC. |
K002897 |
09/18/2000 |
TITANIUM MIDDLE EAR PROSTHESES |
XOMED, INC. |
K964484 |
11/07/1996 |
KARTUSH TM PATCHER |
XOMED, INC. |
K984363 |
12/07/1998 |
XPS TISSUE ASPIRATION SYSTEM, XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM |
XOMED, INC. |
K964909 |
12/09/1996 |
ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS |
XOMED, INC. |
K965233 |
12/31/1996 |
SHARPSITE AC |
XOMED, INC. |
K960853 |
03/01/1996 |
ACE SYSTEM |
XOMED, INC. |
K982594 |
07/24/1998 |
ENDO-SCRUB/ENDO-SCRUB 2 |
XOMED, INC. |
K973273 |
09/02/1997 |
XOMED T-STENT, FRONTAL SINUS STENT |
XOMED, INC. |
K983025 |
08/31/1998 |
XOMED FEATHERTOUCH XPS POWER RASP ATTACHMENT |
XOMED, INC. |
K002395 |
08/07/2000 |
MODEL 30 CLASSIC PNEUMATONOMETER |
XOMED, INC. |
K992282 |
07/07/1999 |
MICRO-FRANCE LIPOSUCTION CANNULAS |
XOMED, INC. |
K992869 |
08/25/1999 |
XOMED BALL-TIP MONOPOLAR STIMULATOR PROBE |
XOMED, INC. |
K002828 |
09/11/2000 |
XPS NITRO SYSTEM |
XOMED, INC. |
K993112 |
09/17/1999 |
XOMED ENT RF SYSTEM |
XOMED, INC. |
K002987 |
09/25/2000 |
REDTRONIC XOMED MONOPOLAR ENERGIZED BLADE |
XOMED, INC. |
K993653 |
10/29/1999 |
MICRO-FRANCE TROCARS AND ACCESSORIES |
XOMED, INC. |
K993655 |
10/29/1999 |
MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS |
XOMED, INC. |
K994262 |
12/17/1999 |
FRONTAL SINUS TREPHINATION CANNULA |
XOMED, INC. |
K982294 |
06/30/1998 |
XOMED SILICONE PRE-FORM BLOCKS |
XOMED, INC. |
K982731 |
08/05/1998 |
MEROGEL NASAL DRESSING AND SINUS STENT |
XOMED, INC. |
K982870 |
08/14/1998 |
EPIFILM OTOLOGIC LAMINA |
XOMED, INC. |
K993582 |
10/22/1999 |
MODIFICATION TO LASER-SHIELD II |
XOMED, INC. |
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