Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1045254

FEI Number

1045254

Entity Name

MEDTRONIC XOMED, INC.

City/State/Country

Jacksonville, FL, US

Establishment Address

6743 SOUTHPOINT DR. NORTH, Jacksonville, FL 32216, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Medtronic, Inc. (Owner Number: 2112641)

Owner / Operator Contact Address

710 Medtronic Parkway, Minneapolis, MN 55432, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K850108

PMA Number

N/A

All Registered 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 NIM XPS NIM 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 Various partial prosthesis 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 NIM NIM Eclipse 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 NIM 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 XPS 3000 XPS Nexus" ENT Power Console System and Components 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 NIM Eclipse Various Otology Vent Tubes NIM SPINE SYSTEM NIM Bone Mill Ossicular Prosthesis Irrigator, Sinus Various Polyethylene Ossic Replace Fisch Modified Total; Fisch Spandrel II Total with Shoe Endoscrub 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 NIM PRS Silicone Instrument Spray AUSTIN ENDOLYMPH DISPERSMENT SHUNT CATHETER, IRRIGATION Various Otology Vent Tubes Donaldson Goode T-Tube Paparella TNE-2000 Esophagoscope NIM Eclipse Varistim III Endosheath system 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 Endosheath system Feathertouch XPS Nasal Septal Button NIM Eclipse XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole XPS Straightshot NIM NIM Eclipse Various total prosthesis NIM Mortez Fisch NIM Eclipse Juhn Tym-Tap Middle Ear Fluid Aspirator/Collector MeroPack Various XPS Alinity i HAVAb IgG Controls (LN 08P2710) Various total prosthesis Silicone Sheets NIM Eclipse

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2008-02-05
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2020-10-30
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2020-10-30
LRE	Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Sterile	Ear, Nose, Throat	Class 1	874.3540	1992-07-20
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2008-01-17
EQJ	Bur, Ear, Nose And Throat	Ear, Nose, Throat	Class 1	874.4140	2003-05-08
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2008-01-16
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	1995-04-14
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2018-04-24
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2001-03-30
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2013-12-03
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2008-01-17
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2016-03-29
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2013-11-07
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2008-01-10
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2008-01-17
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2015-02-02
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2008-01-17
KMA	Irrigator, Powered Nasal	Ear, Nose, Throat	Class 1	874.5550	2009-04-02
NOK	Material, External Aesthetic Restoration, No Adhesive	General, Plastic Surgery	Class 1	878.3800	2017-01-24
JYM	Inserter, Myringotomy Tube	Ear, Nose, Throat	Class 1	874.4420	1994-11-10
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	1995-08-10
ETD	Tube, Tympanostomy	Ear, Nose, Throat	Class 2	874.3880	2008-01-17
EOX	Esophagoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4710	2008-12-12
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2023-09-21
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2008-01-10
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2008-01-17
HBB	Motor, Drill, Pneumatic	Neurology	Class 2	882.4370	2019-05-22
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2019-05-22
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2019-05-22
HBC	Motor, Drill, Electric	Neurology	Class 2	882.4360	2019-05-22
HSZ	Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2019-05-22
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2008-01-16
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2008-07-15
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	1992-12-21
EQJ	Bur, Ear, Nose And Throat	Ear, Nose, Throat	Class 1	874.4140	2014-01-15
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2022-04-04
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2015-01-05
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2008-01-16
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2008-01-17
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2013-11-07
KHJ	Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)	Ear, Nose, Throat	Class 2	874.3620	2015-06-30
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2008-01-31
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2008-01-31
NQP	Posterior Metal/Polymer Spinal System, Fusion	Orthopedic	Class 2	888.3070	2008-01-31
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2008-01-31
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2008-01-31
KWF	Prosthesis, Finger, Polymer	Orthopedic	Class 2	888.3230	2008-01-31
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2020-05-26
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2020-05-26
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2020-05-26
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2017-05-30
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2017-05-30
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2017-05-30
KFK	Saw, Pneumatically Powered	General, Plastic Surgery	Class 1	878.4820	2017-05-30
HBC	Motor, Drill, Electric	Neurology	Class 2	882.4360	2017-05-30
EQJ	Bur, Ear, Nose And Throat	Ear, Nose, Throat	Class 1	874.4140	2017-05-30
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2017-05-30
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2011-03-22
IKT	Electrode, Needle, Diagnostic Electromyograph	Physical Medicine	Class 2	890.1385	2011-03-22
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2011-03-22
EPP	Splint, Nasal	Ear, Nose, Throat	Class 1	874.5800	1992-07-20
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2008-10-27
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2008-10-27
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2008-10-27
HBC	Motor, Drill, Electric	Neurology	Class 2	882.4360	2008-10-27
HBA	Neurosurgical Paddie	Neurology	Class 2	882.4700	2007-12-27
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2009-03-11
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2009-03-11
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2008-01-10
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2016-05-03
ETA	Replacement, Ossicular Prosthesis, Total	Ear, Nose, Throat	Class 2	874.3495	2008-01-17
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2008-01-10
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2013-09-07
ONO	Neurosurgical Laser With Mr Thermography	General, Plastic Surgery	Class 2	878.4810	2026-03-17
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2026-03-17
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2008-01-16
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2008-07-15
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2022-01-25
ONO	Neurosurgical Laser With Mr Thermography	General, Plastic Surgery	Class 2	878.4810	2022-01-25
EPW	Support, Head, Surgical, Ent	General, Plastic Surgery	Class 1	878.4950	2008-01-10
LXB	Hearing Aid, Bone Conduction	Ear, Nose, Throat	Class 2	874.3302	2015-11-06
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2021-01-29
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2008-01-17
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2013-11-07
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2013-11-07
ETD	Tube, Tympanostomy	Ear, Nose, Throat	Class 2	874.3880	2008-01-17
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2008-01-17
LYS	Bone Mill	Orthopedic	Class 1	888.4540	2006-09-06
ETA	Replacement, Ossicular Prosthesis, Total	Ear, Nose, Throat	Class 2	874.3495	2011-02-03
KAR	Irrigator, Sinus	Ear, Nose, Throat	Class 1	874.4420	1994-11-09
LBM	Porous Polyethylene Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2008-01-11
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2014-02-10
PNZ	Eustachian Tube Balloon Dilation Device	Ear, Nose, Throat	Class 2	874.4180	2021-08-23
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2008-01-11
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2015-02-11
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2008-06-05
KAH	Microrule, Ent	Ear, Nose, Throat	Class 1	874.4420	2015-09-15
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2008-01-10
NNO	Jig, Piston Cutting, Ent, Non-Sterile	Ear, Nose, Throat	Class 1	874.3540	2015-09-15
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2006-11-07
LTB	Cyclosporine Radioimmunoassay	Clinical Chemistry	Class 2	862.1235	2015-10-15
ESZ	Tube, Shunt, Endolymphatic	Ear, Nose, Throat	Class 2	874.3820	2008-01-10
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	1995-08-10
ETD	Tube, Tympanostomy	Ear, Nose, Throat	Class 2	874.3880	2008-01-17
ETD	Tube, Tympanostomy	Ear, Nose, Throat	Class 2	874.3880	2008-04-17
EOX	Esophagoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4710	2015-10-15
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2013-11-07
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2013-11-07
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2013-11-07
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2013-11-07
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2013-11-07
GWE	Stimulator, Photic, Evoked Response	Neurology	Class 2	882.1890	2013-11-07
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2009-02-23
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2008-07-15
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2015-08-05
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2015-08-05
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2015-08-05
HBC	Motor, Drill, Electric	Neurology	Class 2	882.4360	2015-08-05
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	1992-08-11
FST	Light, Surgical, Fiberoptic	General, Plastic Surgery	Class 2	878.4580	2015-06-12
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2006-10-03
GFF	Bur, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4820	2003-05-08
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2023-11-15
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2008-10-27
EOX	Esophagoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4710	2008-07-15
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2015-10-15
LFB	Button, Nasal Septal	Unknown	Class U	N/A	2008-01-11
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2013-11-07
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2015-08-31
QPB	System, Suction, Lipoplasty For Removal	General, Plastic Surgery	Class 2	878.5040	2015-10-15
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2009-06-30
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2013-11-07
ETA	Replacement, Ossicular Prosthesis, Total	Ear, Nose, Throat	Class 2	874.3495	2008-01-17
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2008-01-17
LBN	Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene	Ear, Nose, Throat	Class 2	874.3495	2008-01-11
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2015-10-15
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2013-11-07
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2015-10-15
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2015-07-06
EQJ	Bur, Ear, Nose And Throat	Ear, Nose, Throat	Class 1	874.4140	2008-01-16
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2008-01-16
MJY	Kit, Serological, Negative Control	Clinical Chemistry	Class 1	862.1660	2020-10-14
ETA	Replacement, Ossicular Prosthesis, Total	Ear, Nose, Throat	Class 2	874.3495	2008-01-17
KHJ	Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)	Ear, Nose, Throat	Class 2	874.3620	2008-01-17
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2015-10-15

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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Medtronic, Inc.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1045254. Last updated year: 2026. Please use registration number 1045254 when referencing this establishment in official correspondence.