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.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact