Xomed, Inc.
Medical device manufacturer in Jacksonville, FL.
82510(k) clearances
0PMA approvals
0recalls
Device types
- ETD Tube, Tympanostomy 13
- LXB Hearing Aid, Bone Conduction 6
- ERL Drill, Surgical, Ent (Electric Or… 5
- KHJ Polymer, Ent Synthetic-Polyamide (Mesh Or… 5
- ETB Prosthesis, Partial Ossicular Replacement 3
- GEI Electrosurgical, Cutting & Coagulation &… 3
- KAM Cannula, Sinus 3
- JOF Polymer, Ent Synthetic, Porous Polyethylene 2
- HRX Arthroscope 2
- EOB Nasopharyngoscope (Flexible Or Rigid) 2
- QPB System, Suction, Lipoplasty For Removal 2
- ETN Stimulator, Nerve 2
- EPP Splint, Nasal 2
- GAD Retractor 1
- HKX Tonometer, Ac-Powered 1
- KCN Ear Wick 1
- EPY Speculum, Ent 1
- KBD Scissors, Nasal 1
- JYR Nipper, Malleus 1
- LFB Button, Nasal Septal 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K002395 | Model 30 Classic PneumatonometerHKX · Traditional | 12/11/2000SE |
| K002987 | Redtronic Xomed Monopolar Energized BladeGEI · Traditional | 12/04/2000SE |
| K002828 | XPS Nitro SystemERL · Traditional | 10/17/2000SE |
| K002897 | Titanium Middle Ear ProsthesesETB · Traditional | 10/11/2000SE |
| K993653 | Micro-France Trocars and AccessoriesHET · Traditional | 06/09/2000SE |
| K001148 | Merogel Otologic PackKHJ · Traditional | 06/03/2000SE |
| K994262 | Frontal Sinus Trephination CannulaKAM · Traditional | 02/08/2000SE |
| K992855 | XPS Straightshot or Model 2000 Microdebrider System or XPS PowersculptQPB · Traditional | 01/21/2000SE |
| K993582 | Modification to Laser-Shield IIBTR · Traditional | 01/20/2000SE |
| K993655 | Micro-France Electrosurgical Instruments, VariousGEI · Traditional | 12/21/1999SE |
| K993112 | Xomed ENT RF SystemGEI · Traditional | 12/09/1999SE |
| K992869 | Xomed Ball-Tip Monopolar Stimulator ProbeETN · Traditional | 10/07/1999SE |
| K992282 | Micro-France Liposuction CannulasQPB · Traditional | 09/23/1999SE |
| K984363 | XPS Tissue Aspiration System, XPS Straightshot or Model 2000 Microdebrider SystemBTA · Traditional | 02/26/1999SE |
| K982731 | Merogel Nasal Dressing and Sinus StentEMX · Traditional | 02/02/1999SE |
| K983025 | Xomed Feathertouch XPS Power Rasp AttachmentHRX · Traditional | 11/06/1998SE |
| K982870 | Epifilm Otologic LaminaKHJ · Traditional | 11/03/1998SE |
| K983224 | XPS Drill SystemERL · Traditional | 10/21/1998SE |
| K982294 | Xomed Silicone Pre-Form BlocksKHJ · Traditional | 09/18/1998SE |
| K982595 | NIM4ETN · Traditional | 09/04/1998SE |
| K982594 | Endo-Scrub/Endo-Scrub 2EOB · Traditional | 08/27/1998SE |
| K973499 | XPS Straightshot Microbrider System or Trebay Shaver SystemHRX · Traditional | 01/30/1998SE |
| K973273 | Xomed T-Stent, Frontal Sinus StentKAM · Traditional | 09/29/1997SE |
| K972453 | XPS Straightshot MicroresectorERL · Traditional | 09/05/1997SE |
| K971124 | TM Micro-CathetersETD · Traditional | 05/16/1997SE |
| K970910 | Xomed Silicone Block/StripKHJ · Traditional | 05/02/1997SE |
| K965233 | Sharpsite AcEOB · Traditional | 04/04/1997SE |
| K964909 | Esterm Malleus Total and Partial Middle Ear ProsthesisETB · Traditional | 03/10/1997SE |
| K964484 | Kartush TM PatcherKHJ · Traditional | 01/24/1997SE |
| K961873 | Activent Antimicrobial Ventilation TubesETD · Traditional | 07/01/1996SE |
| K960853 | Ace SystemEQJ · Traditional | 04/03/1996SE |
| K901016 | Laser-Shield Ii(Tm)GEX · Traditional | 08/29/1990SE |
| K884631 | Flexible Endoscope 91-8200(90) and 91-82100(135)LRC · Traditional | 03/22/1989SE |
| K884834 | Xomed Ionesthetizer(Tm)EGJ · Traditional | 02/15/1989SESD |
| K884056 | Modified Implant for Xomed Audiant Bone ConductorLXB · Traditional | 11/30/1988SE |
| K882689 | Punch Myringotomy SystemETD · Traditional | 09/13/1988SE |
| K881382 | Xomed Audiant Bone ConductorLXB · Traditional | 06/21/1988SE |
| K875277 | Additional Indications for Xomed Audiant Bone Con.LXB · Traditional | 03/14/1988SE |
| K872112 | Xomed Platinum Wire Teflon PistionETB · Traditional | 07/02/1987SE |
| K872168 | Xomed Audiant Bone Conductor at the Ear Sound Pro.LXB · Traditional | 06/30/1987SE |
| K861971 | Xomed Audiant Bone Conductor W/Improved Aa CoilLXB · Traditional | 05/30/1986SE |
| K855059 | Audiant Bone Conductor or A.B.C.LXB · Traditional | 04/03/1986SE |
| K860491 | Osteo-Mesh Cranial Fairing · Traditional | 03/28/1986SE |
| K853641 | Godde T-Tube Blue Silicone Tympanostomy TubeETD · Traditional | 01/06/1986SE |
| K852387 | Goode T-Tube White Silicone Tympanostomy TubeETD · Traditional | 01/06/1986SE |
| K832404 | Rectal Temp. Telemetry MonitorFLL · Traditional | 09/12/1983SE |
| K831127 | Intra-Oral Artificial LarynxESE · Traditional | 07/28/1983SE |
| K822790 | Micro-Craft Oscillating Saw HandpieceKIJ · Traditional | 10/22/1982SE |
| K821904 | Xomed Mandibular TrayJAZ · Traditional | 07/26/1982SE |
| K821373 | Xomed Patency MonitorDPW · Traditional | 07/08/1982SE |
| K813224 | Ceravital Ceramic Ear Canal Wall ProsthESF · Traditional | 04/21/1982SE |
| K820157 | Xomed Thermal Myringotomy SystemHQP · Traditional | 03/02/1982SE |
| K813475 | Xomed Micro-IrrigatorFQH · Traditional | 02/04/1982SE |
| K813474 | Maxill-Air Sinus Ventilation TubeKAM · Traditional | 01/12/1982SE |
| K810707 | Ceravital Ceramic Ossicular Repl. Pros.ETA · Traditional | 06/16/1981SE |
| K810738 | Goode Magnetic Nasal SplintEPP · Traditional | 03/31/1981SE |
| K810020 | Panje Voice ProsthesisEWL · Traditional | 02/05/1981SE |
| K800728 | Paparell Type 2, Biolite Coated Sili-ETD · Traditional | 04/16/1980SE |
| K800727 | Goode T-Tube, Biolite Coated Silicone/TuETD · Traditional | 04/16/1980SE |
| K792330 | Xomed Microsurgery Background · Traditional | 12/06/1979SE |
| K791680 | Pope Umbrella TubeETD · Traditional | 11/13/1979SE |
| K791681 | The Denver SplintEPP · Traditional | 10/22/1979SE |
| K791736 | Merocel Instrument WipeGEC · Traditional | 09/19/1979SE |
| K791407 | Womed Nicro-Craft Power SystemERL · Traditional | 08/22/1979SE |
| K791059 | Pope Oto-Wick, Sterile & Non-SterileKCN · Traditional | 07/17/1979SE |
| K791123 | Ear and Nose SpeculaEPY · Traditional | 07/10/1979SE |
| K791122 | Tissure RetractorsGAD · Traditional | 07/10/1979SE |
| K791120 | Middle Ear Picks, Hooks Curettes,GDG · Traditional | 07/10/1979SE |
| K791124 | Surgical ScissorsKBD · Traditional | 06/27/1979SE |
| K791121 | Alligator Forecpts, Cupped ForcepsJYR · Traditional | 06/27/1979SE |
| K790915 | Juhn Tym-TapFMH · Traditional | 06/27/1979SE |
| K790216 | Ventilation Tube, Sheehy CollatETD · Traditional | 02/12/1979SE |
| K781529 | Septal ButtonLFB · Traditional | 10/17/1978SE |
| K781418 | Xomed Transsphenoidal HandpieceERL · Traditional | 08/31/1978SE |
| K781260 | Ventilation Tube Silicone Paparella TypeETD · Traditional | 08/14/1978SE |
| K781259 | Ventilation Tube Teflon Shepard TypeETD · Traditional | 08/14/1978SE |
| K781258 | Ventilation Tube. Sili. Donaldson TypeETD · Traditional | 08/14/1978SE |
| K781257 | Ventilation Tube Sili. Sheppard TypeETD · Traditional | 08/14/1978SE |
| K771727 | Biosponge Reconstruction DiscsJOF · Traditional | 09/26/1977SE |
| K771726 | Biosponge Stapes PistonJOF · Traditional | 09/26/1977SE |
| K771725 | Biosp. Total Ossicular Replace. Prosthe.FEX · Traditional | 09/26/1977SE |
| K760570 | Robinson Middle Ear ProsthesisEIB · Traditional | 09/21/1976SE |