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MEDTRONIC XOMED, INC.

Last updated September 17, 2026

Information

Country: US
Address: 6743 SOUTHPOINT DR. NORTH, Jacksonville, FL, 32216
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1045254
DUNS Number: —

Catalogue (1955)

Page 39 of 40

Device	Model / Reference	Registries	Class	Status
Cohen	25691	FDA UDI	Class II	Unknown
C-Flex®	1066032	FDA UDI	Class II	Active
Rad®	1884016	FDA UDI	Class I	Active
Mortez	1156359	FDA UDI	Class II	Unknown
Reuter	1010203	FDA UDI	Class II	Active
Causse / Flex H/A®	0528	FDA UDI	Class II	Active
Shepard	1016301	FDA UDI	Class II	Active
Shah	1018101	FDA UDI	Class II	Active
Endo-Scrub®	1912032	FDA UDI	Class II	Active
Nim-Prs	K024316	FDA 510(k)	Class II	Active
Merogel Control Gel Ent Surgical Dressing	K002972	FDA 510(k)	Class II	Active
Ventilation (Tympanostomy) Tubes	K151067	FDA 510(k)	Class II	Active
Stimulating Bur Guard	K063305	FDA 510(k)	Class II	Active
NuVent Eustachian Tube Dilation Balloon	K210841	FDA 510(k)	Class II	Active
Microfrance Laparoscopic Manual Surgical Instruments	K080257	FDA 510(k)	Class II	Active
Microfrance(r) Wormald Vascular Clamp	K112662	FDA 510(k)	Class II	Active
NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tube (NIMEID065); NIM Essence™ EMG Endotracheal Tube (NIMEID070); NIM Essence™ EMG Endotracheal Tube (NIMEID075); NIM Essence™ EMG Endotracheal Tube (NIMEID080)	K251672	FDA 510(k)	Class II	Active
ALAR Nasal Valve Stent	K151758	FDA 510(k)	Class II	Active
Xps 3000 System	K041413	FDA 510(k)	Class II	Active
Xps 3000 System With Reciprocating Adapter And Suction Cannulae	K010666	FDA 510(k)	Class II	Active
Framelock; Framelock Accessories	K022370	FDA 510(k)	Class II	Active
NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)	K231580	FDA 510(k)	Class II	Active
Modification To Xps 3000 System	K011321	FDA 510(k)	Class II	Active
Stimulus/Dissection Instruments, Ball-Tip Probes	K031003	FDA 510(k)	Class II	Active
Contact Emg Rotatable Endotracheal Tube	K050162	FDA 510(k)	Class II	Active
Hoffman H/A Coated Long-Term Ventilation Tube With Liner	K963727	FDA 510(k)	Class II	Active
NuVent EM Sinus Dilation System	K152121	FDA 510(k)	Class I	Active
Tono-Pen Avia Tonometer And Ocu-Shiled Tip Cover	K053430	FDA 510(k)	Class II	Active
Sharpsite AC Rigid Endsocope	K173855	FDA 510(k)	Class II	Active
NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long	K213246	FDA 510(k)	Class II	Active
Stimulus - Dissection Instruments	K014165	FDA 510(k)	Class II	Active
Xps Curved Bur	K041985	FDA 510(k)	Class I	Active
Merocel Cornell Lid And Lash Guard, Merocel And Kerocel Ophthalmic Sponges	K011191	FDA 510(k)	Class II	Active
NIM Vital, Nerve Integrity Monitor	K200759	FDA 510(k)	Class II	Active
Novapak Nasal Sinus Packing and Stent	K202623	FDA 510(k)	Class I	Active
Accuguide Muscle Injection Monitor	K990793	FDA 510(k)	Class II	Active
Xps 4000 System, Midas Rex Legend Ehs System, Integrated Power Cons0le (ipc)	K081277	FDA 510(k)	Class II	Active
Nim-Spine	K031510	FDA 510(k)FDA UDI	Class II	Active
NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube	K230320	FDA 510(k)	Class II	Active
Meropack Bioresorbable Nasal Packing And Sinus Stent	K041381	FDA 510(k)	Class I	Active
Next Gen Emg Endotracheal Tube	K112686	FDA 510(k)	Class II	Active
Ipc Powerease System	K111520	FDA 510(k)	Class II	Active
Pillar Palatal Implant System	K110623	FDA 510(k)	Class II	Active
Medtronic Solan Fiberoptic Corneal Light Probe	K000728	FDA 510(k)	Class II	Active
Electric Drill System [xps 4000 System, Midas Rex Legend Ehs System, Integrated Power Console (ipc)]	K081475	FDA 510(k)	Class II	Active
Merogel Injectable Bioresorbable Nasal Dressing And Sinus Stent And Otologic Gel	K122434	FDA 510(k)	Class II	Active
Em Sinus Dilation System	K132297	FDA 510(k)	Class I	Active
XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole	K150728	FDA 510(k)	Class II	Active
Xps 3000 System	K002224	FDA 510(k)	Class II	Active
Xps 3000 System	K010677	FDA 510(k)	Class II	Active

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FDA Recalls (38)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jul 17, 2025	Z-2461-2025	—	open, classified	Due to out of the box wobble of the driver.
Mar 10, 2025	Z-1623-2025	—	open, classified	Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention.
Jul 5, 2024	Z-3130-2024	—	open, classified	Product was distributed past expiration date.
Jun 24, 2024	Z-2409-2024	—	open, classified	Potential for false negative response on the NIM Vital Nerve Monitoring System
Nov 7, 2023	Z-0696-2024	—	open, classified	Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring,
May 3, 2022	Z-1224-2022	—	open, classified	Software anomaly was identified.
May 3, 2022	Z-1223-2022	—	open, classified	Software anomaly was identified.
Apr 29, 2022	Z-1521-2022	—	open, classified	The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.
Apr 29, 2022	Z-1520-2022	—	open, classified	The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.
Apr 29, 2022	Z-1519-2022	—	open, classified	The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.
Dec 22, 2021	Z-0743-2022	—	open, classified	There is potential for multiple issues due to a manufacturing nonconformity.
Dec 15, 2021	Z-0961-2022	—	terminated	As a result of Medtronic's integrated power console (authentication number: 222ACBZX00018000) being used with software version: v2.7.3.0, it was discovered that there was a defect that resulted in a difference between the set number of rotations and the actual number of rotations in a specific mode when the product was used with our company's M5 handpiece.
Aug 31, 2021	Z-0156-2022	—	open, classified	There was an increase in complaints related to tip breaks and wobble/vibration.
Aug 31, 2021	Z-0158-2022	—	open, classified	There was an increase in complaints related to tip breaks and wobble/vibration.
Aug 31, 2021	Z-0157-2022	—	open, classified	There was an increase in complaints related to tip breaks and wobble/vibration.
Jun 12, 2020	Z-2673-2020	—	terminated	During internal testing execution of the next generation of Integrated Power Console (IPC) prototype it was noted that the M5 Microdebrider was rotating at a higher speed than the set value in the cosole.
Nov 13, 2019	Z-0735-2020	—	open, classified	Routine sterilization dose does not meet the required Sterility Assurance Level.
Nov 13, 2019	Z-0733-2020	—	open, classified	Routine sterilization dose does not meet the required Sterility Assurance Level.
Nov 13, 2019	Z-0734-2020	—	open, classified	Routine sterilization dose does not meet the required Sterility Assurance Level.
Jun 28, 2016	Z-0901-2017	—	terminated	Wire in tubing can become exposed, posing potential harm to the intubated patient.
Aug 23, 2013	Z-2284-2013	—	terminated	One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft.
Jul 9, 2013	Z-1934-2013	—	terminated	The firm will recall and replace the identified instrument trays in the field, with trays that have improved labeling, including lids that contain the statement indicating 'PREVACUUM ONLY"
Mar 4, 2013	Z-1420-2013	—	terminated	In March 2013, Medtronic issued a recall of the NIM TriVantage EMG Endotracheal Tube due to cuff leakage in the intraoperative cuff deflation which then requires re-inflation or replacement of the deflated tube in order to ensure the continued ventilation of the patient.
Feb 21, 2011	Z-1699-2011	—	terminated	Medtronic Xomed, Inc. Jacksonville, FL issued a recall on Feb 21, 2011 for all lots of the alcohol pad packaged with the Medtronic's External Nasal Splints REF 1528116 (sm), 1528126 (med), 1528136 (lg) and the Thermasplints REF 1529100 (sm), 1529110 (med), and 1529120 (lg) distributed from Jan 2008 through Aug 2010. The alcohol supplier, Cardinal Health, issued a recall on the alcohol pads on Jan
Feb 21, 2011	Z-1700-2011	—	terminated	Medtronic Xomed, Inc. Jacksonville, FL issued a recall on Feb 21, 2011 for all lots of the alcohol pad packaged with the Medtronic's External Nasal Splints REF 1528116 (sm), 1528126 (med), 1528136 (lg) and the Thermasplints REF 1529100 (sm), 1529110 (med), and 1529120 (lg) distributed from Jan 2008 through Aug 2010. The alcohol supplier, Cardinal Health, issued a recall on the alcohol pads on Jan
Sep 27, 2010	Z-2344-2012	—	terminated	In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0 detects the signal loss from the electrode (i.e. open channel), it fails the electrode check and provides an audible and visual warning to the user which could also create a delay in the surgical procedu
Sep 27, 2010	Z-2342-2012	—	terminated	In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0 detects the signal loss from the electrode (i.e. open channel), it fails the electrode check and provides an audible and visual warning to the user which could also create a delay in the surgical procedu
Sep 27, 2010	Z-2343-2012	—	terminated	In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0 detects the signal loss from the electrode (i.e. open channel), it fails the electrode check and provides an audible and visual warning to the user which could also create a delay in the surgical procedu
Jul 27, 2009	Z-0536-2010	—	terminated	Medtronic Xomed, Inc. is recalling the Repose Bone Screw System product and Bone Screw product due to improper labeling. The labeling for the Repose System was inadvertently placed on the Repose Screw and vice versa.
Jul 27, 2009	Z-0535-2010	—	terminated	Medtronic Xomed, Inc. is recalling the Repose Bone Screw System product and Bone Screw product due to improper labeling. The labeling for the Repose System was inadvertently placed on the Repose Screw and vice versa.
Jul 17, 2009	Z-0259-2010	—	terminated	An error code (Code 13) is displayed on some of the consoles when a Medtronic Stylus or EHS handpiece is connected to the IPC indicating that the handpiece has not been recognized by the console.
Nov 21, 2008	Z-0947-2009	—	terminated	Device may fail to operate or operate intermittently during use and such operation could result in a lack of nerve stimulation when nerve tissue is actually contacted by the stimulator.
Jan 22, 2007	Z-0576-2007	—	terminated	A labeling discrepancy was internally identified for the surface electrode component of REF 8263210 AccuGuide EMG Injection Needle, 30G X 25MM. The outside box label correctly indicates 'Content: 5 sterile Injection Needles and 10 non-sterile Surface electrodes'; however, the pouches for the 10 surface electrodes inside the box are incorrectly labeled as 'sterile'.
Oct 29, 2004	Z-0310-05	—	terminated	The firm received six reports of tubes with wires 'out of channel' two of which involved injuried patients. In one case in Germany it was reported that the patient had soreness of the throat and was discharged after four days. In the next case the patient had a tracheal wound. It was not clear what caused the wound.
Jan 29, 2004	Z-0953-04	—	terminated	The curve in the shaft of the bur was only 15 degrees not the labeled 40 degrees.
Jan 29, 2004	Z-0954-04	—	terminated	The sheaths in question have shafts that are one inch longer than required for the endoscope specified on the label.
Jan 29, 2004	Z-0955-04	—	terminated	The box label indicates that the product is a size 2 whereas a size 4 was packed inside.
Jan 25, 2002	Z-0662-03	—	terminated	Product packaging pouches may be open thereby compomising the sterile barrier.