FDA Registration
Active
🇺🇸 United States
MEDTRONIC XOMED, INC.
Reg #: 1045254
·
FEI: 1045254
·
Expires 2026
Products
81
Proprietary Names
155
Establishment Types
4
Classifications
81
Registration Details
- Registration Name
- MEDTRONIC XOMED, INC.
- Registration Number
- 1045254
- FEI Number
- 1045254
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6743 SOUTHPOINT DR. NORTH
- City
- Jacksonville
- State
- FL
- ZIP
- 32216
- Country
- US
Regulatory Submissions
- 510(k) Number
- K993021
Owner / Operator
- Firm Name
- Medtronic, Inc.
- Operator Number
- 2112641
- Address
- 710 Medtronic Parkway
- City
- Minneapolis
- State
- MN
- Postal Code
- 55432
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2008-02-05 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2020-10-30 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2020-10-30 |
| Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Sterile | LRE | Class 1 | Ear, Nose, Throat | No | 1992-07-20 |
| Bur, Ear, Nose And Throat | EQJ | Class 1 | Ear, Nose, Throat | No | 2003-05-08 |
| Electrode, Needle | GXZ | Class 2 | Neurology | No | 2008-01-16 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 1995-04-14 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2018-04-24 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2001-03-30 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2013-12-03 |
| Prosthesis, Partial Ossicular Replacement | ETB | Class 2 | Ear, Nose, Throat | No | 2008-01-17 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2016-03-29 |
| Irrigator, Powered Nasal | KMA | Class 1 | Ear, Nose, Throat | No | 2009-04-02 |
| Material, External Aesthetic Restoration, No Adhesive | NOK | Class 1 | General, Plastic Surgery | No | 2017-01-24 |
| Inserter, Myringotomy Tube | JYM | Class 1 | Ear, Nose, Throat | No | 1994-11-10 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 1995-08-10 |
| Tube, Tympanostomy | ETD | Class 2 | Ear, Nose, Throat | No | 2008-01-17 |
| Esophagoscope (Flexible Or Rigid) | EOX | Class 2 | Ear, Nose, Throat | No | 2008-12-12 |
| Stylet, Tracheal Tube | BSR | Class 1 | Anesthesiology | No | 2008-01-10 |
| Motor, Drill, Pneumatic | HBB | Class 2 | Neurology | No | 2019-05-22 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2019-05-22 |
| Motor, Drill, Electric | HBC | Class 2 | Neurology | No | 2019-05-22 |
| Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | HSZ | Class 1 | General, Plastic Surgery | No | 2019-05-22 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 1992-12-21 |
| Device, Anti-Snoring | LRK | Class 2 | Dental | No | 2015-01-05 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2013-11-07 |
| Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | KHJ | Class 2 | Ear, Nose, Throat | No | 2015-06-30 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2008-01-31 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2008-01-31 |
| Posterior Metal/Polymer Spinal System, Fusion | NQP | Class 2 | Orthopedic | No | 2008-01-31 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2008-01-31 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2008-01-31 |
| Prosthesis, Finger, Polymer | KWF | Class 2 | Orthopedic | No | 2008-01-31 |
| Pump, Infusion | FRN | Class 2 | General Hospital | No | 2020-05-26 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2020-05-26 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2020-05-26 |
| Saw, Pneumatically Powered | KFK | Class 1 | General, Plastic Surgery | No | 2017-05-30 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2017-05-30 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2011-03-22 |
| Electrode, Needle, Diagnostic Electromyograph | IKT | Class 2 | Physical Medicine | No | 2011-03-22 |
| Splint, Nasal | EPP | Class 1 | Ear, Nose, Throat | No | 1992-07-20 |
| Neurosurgical Paddie | HBA | Class 2 | Neurology | No | 2007-12-27 |
| Replacement, Ossicular Prosthesis, Total | ETA | Class 2 | Ear, Nose, Throat | No | 2008-01-17 |
| Neurosurgical Laser With Mr Thermography | ONO | Class 2 | General, Plastic Surgery | No | 2026-03-17 |
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2008-01-16 |
| Support, Head, Surgical, Ent | EPW | Class 1 | General, Plastic Surgery | No | 2008-01-10 |
| Hearing Aid, Bone Conduction | LXB | Class 2 | Ear, Nose, Throat | No | 2015-11-06 |
| Splint, Intranasal Septal | LYA | Class 1 | Ear, Nose, Throat | No | 2021-01-29 |
| Bone Mill | LYS | Class 1 | Orthopedic | No | 2006-09-06 |
| Irrigator, Sinus | KAR | Class 1 | Ear, Nose, Throat | No | 1994-11-09 |
| Porous Polyethylene Ossicular Replacement | LBM | Class 2 | Ear, Nose, Throat | No | 2008-01-11 |
| Eustachian Tube Balloon Dilation Device | PNZ | Class 2 | Ear, Nose, Throat | No | 2021-08-23 |
| Tube, Tracheal (W/Wo Connector) | BTR | Class 2 | Anesthesiology | No | 2008-06-05 |
| Microrule, Ent | KAH | Class 1 | Ear, Nose, Throat | No | 2015-09-15 |
| Jig, Piston Cutting, Ent, Non-Sterile | NNO | Class 1 | Ear, Nose, Throat | No | 2015-09-15 |
| Cyclosporine Radioimmunoassay | LTB | Class 2 | Clinical Chemistry | No | 2015-10-15 |
| Tube, Shunt, Endolymphatic | ESZ | Class 2 | Ear, Nose, Throat | No | 2008-01-10 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 1995-08-10 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2013-11-07 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2013-11-07 |
| Stimulator, Auditory, Evoked Response | GWJ | Class 2 | Neurology | No | 2013-11-07 |
| Full-Montage Standard Electroencephalograph | GWQ | Class 2 | Neurology | No | 2013-11-07 |
| Stimulator, Photic, Evoked Response | GWE | Class 2 | Neurology | No | 2013-11-07 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 1992-08-11 |
| Light, Surgical, Fiberoptic | FST | Class 2 | General, Plastic Surgery | No | 2015-06-12 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2003-05-08 |
| Button, Nasal Septal | LFB | Class U | Unknown | No | 2008-01-11 |
| System, Suction, Lipoplasty For Removal | QPB | Class 2 | General, Plastic Surgery | No | 2015-10-15 |
| Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene | LBN | Class 2 | Ear, Nose, Throat | No | 2008-01-11 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2015-10-15 |
| Kit, Serological, Negative Control | MJY | Class 1 | Clinical Chemistry | No | 2020-10-14 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2018-11-16 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2008-02-04 |
| Light, Surgical, Carrier | FSZ | Class 2 | General, Plastic Surgery | No | 2008-02-04 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2008-02-04 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2013-10-21 |
| Parathyroid Autofluorescence Detection Device | QDF | Class 2 | General, Plastic Surgery | No | 2020-03-27 |
| Cannula, Sinus | KAM | Class 1 | General, Plastic Surgery | No | 2013-09-07 |
| Tube, Ear Suction | JZF | Class 1 | Ear, Nose, Throat | No | 1994-11-09 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2015-10-29 |
| Balloon, Epistaxis | EMX | Class 1 | Ear, Nose, Throat | No | 1995-04-18 |
Proprietary Names
METRx Endoscope
NIM Vital
INSTRUMENT, PROSTHESIS
NIM
MUTIPLE TYPES OF BURS
Needle electrodes
MICRO-FRANCE Manual Surgical Instr
MULTIPLE Manual Surgical Instruments
KyphX Handle; Introducer
XOMED
Visualase
Tray, Surgical, Instrument
instrument tray
Aspen
Bard-Parker
Wire Nest
Skeeter
Various partial prosthesis
NuVent EM Sinus Dilation System
NIM Eclipse
XPS 3000
XPS Nexus" ENT Power Console System and Components
XPS
Powered nasal irrigator
Silverstein Packing Strips
Inserter, Myringotomy Tube
Preset Needles
KyphX 11 Gauge Bone Access Needle
Coaxial
Aspiration Needles
ORO-TRACHEAL INJECTOR NEEDLE
Various Otology Vent Tubes
Endosheath System
Endoscopic Devices
and accessories
NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip
Tube-Stat Lighted Intubation Stylets, Naso-Tracheal; Oro-Tracheal
Stylet
MR8 Drill System
Midas Rex MR8 ClearView Tools
Micro-Craft System
Endosheath system
XPS Nexus
VitalFlow ECMO Cart
XPS Curved Bur
NIM Surgeon Control Probes
Airvance
Various XPS
Silicone Sheaths
CD Engage Cap
Visualase Thermal Therapy System
Midas Rex Legend Surgical Dissecting Tools
IPC - Integrated Power Console Drill System
Clearview Surgical Dissecting Tools
Midas Rex Legend Attachments
Midas Rex Legend Drill System
BRIDGEMASTER SPLINT
Irrigation Tubing Sets
Saw Blades
Saw Handpieces (Reciprocating, Oscillating, Sagittal)
Microsaw Rasps
Integrated Power Console
Foot Control
Cooling Tubing Sets
Cranial/Ortho/Neuro Elec Drill Sys
Neuray Surgical Patties and Strips
NIM 3 Nerve Stimulator
Sharpsite ENT Endoscope
Various total prosthesis
Endoscrub
Endo-Scrub 2 Lens Cleaning System;Endo-Scrub 2 Lens Cleaning Sheaths
Nasopharyngoscope
Visualase Cooled Laser Applicator System
NIM PRS
Sensory Testing Endosheath System
ONO
BIOFLEK
Otomag Alpha 2 Sound Processor
Hi-Pro Programming Cable
Fitting Software
Otomag Binural Softband
Otomag Monaural Softband
Otomag Headband
Novapak
NIM SPINE SYSTEM
Bone Mill
Ossicular Prosthesis
Irrigator, Sinus
Various Polyethylene Ossic Replace
Fisch Modified Total; Fisch Spandrel II Total with Shoe
NuVent Eustachian Tube Dilation Balloon
CONTACT EMG Rotatable Endotracheal Tube
Hunsake Mon-jet Ventilation Tube
Otological Metric Scale
Visao High-Speed Otologic Drill
Helix Drill
Moretz Trimming Block
Silicone Instrument Spray
AUSTIN ENDOLYMPH DISPERSMENT SHUNT
CATHETER, IRRIGATION
Donaldson
Goode T-Tube
Paparella
TNE-2000 Esophagoscope
Varistim III
Triton Electric High Torque Handpiece And Accessories
MEROCEL PACKINGS, DRESSINGS, ETC.
Fiberoptic
, MOTORS
DRILLS
SURGICAL DRIVE SYSTEM
MIDAS REX LEGEND EHS SYSTEM
NIM Standard Reinforced EMG Endotracheal Tube
NIM CONTACT Reinforced EMG Endotracheal Tube
ENT Drill & Handpiece, elec & pneu
Feathertouch XPS
Nasal Septal Button
XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole
XPS Straightshot
Mortez
Fisch
Juhn Tym-Tap Middle Ear Fluid Aspirator/Collector
MeroPack
Alinity i HAVAb IgG Controls (LN 08P2710)
Silicone Sheets
Container
CD HORIZON® Spinal System
Thoracolumbosacral pedicle screw system
POWEREASE
MAST QUADRANT Retractor System
Peek Rod
PTEYE PARATHYROID AUTOFLUORESCENCE DETECTION DEVICE
NIM Essence EMG Endotracheal Tube
Trephine Cannula
Xomed Ball-Tip Monopolar Stimulator Probe
Ventilation (Tympanostomy) Tubes
TriVantage EMG Tube
Midas Rex Curved Burs
Anti-snoring device
AccuGuide Injection Monitor
Neddle electrode
StealthStation ENT Application
neurological stereotaxic instrument
Various ENT polymer materials
Stimulator, evoked response
NIM- Spine" System Instruments
Tube, Ear Suction
NuVent
ALAR Nasal Valve Stent
MEROCEL SPONGE
McGee
Various Partial & Total Prosthesis
The Big Easy Piston; Roberson Stapes Prostheses
Ossicular Replacement
NASAL SPLINT
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility