FDA 510(k) Applications Submitted by MEDTRONIC XOMED, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K231580 |
05/31/2023 |
NIMÖ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) |
Medtronic Xomed, Inc. |
| K213246 |
09/30/2021 |
NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long |
Medtronic Xomed, Inc. |
| K081277 |
05/05/2008 |
XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC) |
MEDTRONIC XOMED, INC. |
| K081475 |
05/27/2008 |
ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)] |
MEDTRONIC XOMED, INC. |
| K063305 |
11/01/2006 |
STIMULATING BUR GUARD |
MEDTRONIC XOMED, INC. |
| K022370 |
07/22/2002 |
FRAMELOCK; FRAMELOCK ACCESSORIES |
MEDTRONIC XOMED, INC. |
| K073255 |
11/19/2007 |
XPS 3000 SYSTEM |
MEDTRONIC XOMED, INC. |
| K050162 |
01/25/2005 |
CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE |
MEDTRONIC XOMED, INC. |
| K041381 |
05/25/2004 |
MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT |
MEDTRONIC XOMED, INC. |
| K011191 |
04/19/2001 |
MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES |
MEDTRONIC XOMED, INC. |
| K122391 |
08/07/2012 |
MEDTRONIC XOMED, INC. |
MEDTRONIC XOMED, INC. |
| K150728 |
03/20/2015 |
XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole |
MEDTRONIC XOMED, INC. |
| K152121 |
07/30/2015 |
NuVent EM Sinus Dilation System |
MEDTRONIC XOMED, INC. |
| K080257 |
01/31/2008 |
MICROFRANCE LAPAROSCOPIC MANUAL SURGICAL INSTRUMENTS |
MEDTRONIC XOMED, INC. |
| K083124 |
10/22/2008 |
NIM 3.0 |
MEDTRONIC XOMED, INC. |
| K200759 |
03/24/2020 |
NIM Vital, Nerve Integrity Monitor |
Medtronic Xomed, Inc. |
| K112686 |
09/15/2011 |
NEXT GEN EMG ENDOTRACHEAL TUBE |
MEDTRONIC XOMED, INC. |
| K112662 |
09/13/2011 |
MICROFRANCE(R) WORMALD VASCULAR CLAMP |
MEDTRONIC XOMED, INC. |
| K024316 |
12/26/2002 |
NIM-PRS |
MEDTRONIC XOMED, INC. |
| K010666 |
03/06/2001 |
XPS 3000 SYSTEM WITH RECIPROCATING ADAPTER AND SUCTION CANNULAE |
MEDTRONIC XOMED, INC. |
| K010677 |
03/07/2001 |
XPS 3000 SYSTEM |
MEDTRONIC XOMED, INC. |
| K031003 |
03/31/2003 |
STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES |
MEDTRONIC XOMED, INC. |
| K011321 |
04/27/2001 |
MODIFICATION TO XPS 3000 SYSTEM |
MEDTRONIC XOMED, INC. |
| K041413 |
05/27/2004 |
XPS 3000 SYSTEM |
MEDTRONIC XOMED, INC. |
| K041523 |
06/08/2004 |
XPS 3000 SYSTEM |
MEDTRONIC XOMED, INC. |
| K041985 |
07/23/2004 |
XPS CURVED BUR |
MEDTRONIC XOMED, INC. |
| K014165 |
12/19/2001 |
STIMULUS - DISSECTION INSTRUMENTS |
MEDTRONIC XOMED, INC. |
| K210841 |
03/22/2021 |
NuVent Eustachian Tube Dilation Balloon |
Medtronic Xomed, Inc. |
| K151067 |
04/21/2015 |
Ventilation (Tympanostomy) Tubes |
Medtronic Xomed, Inc. |
| K053430 |
12/09/2005 |
TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER |
MEDTRONIC XOMED, INC. |
| K111520 |
06/02/2011 |
IPC POWEREASE SYSTEM |
MEDTRONIC XOMED, INC. |
| K110623 |
03/03/2011 |
PILLAR PALATAL IMPLANT SYSTEM |
MEDTRONIC XOMED, INC. |
| K132297 |
07/24/2013 |
EM SINUS DILATION SYSTEM |
MEDTRONIC XOMED, INC. |
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