FDA Registration
Active
🇺🇸 United States
INVOTEC INTERNATIONAL, INC.
Reg #: 1052728
·
FEI: 1000113735
·
Expires 2026
Products
34
Proprietary Names
44
Establishment Types
2
Classifications
34
Registration Details
- Registration Name
- INVOTEC INTERNATIONAL, INC.
- Registration Number
- 1052728
- FEI Number
- 1000113735
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 6833 PHILLIPS INDUSTRIAL BLVD.
- City
- Jacksonville
- State
- FL
- ZIP
- 32256
- Country
- US
Regulatory Submissions
- 510(k) Number
- K923689
Owner / Operator
- Firm Name
- INVOTEC INTERNATIONAL, INC.
- Operator Number
- 9000512
- Address
- 6833 PHILLIPS INDUSTRIAL BLVD., --
- City
- Jacksonville
- State
- FL
- Postal Code
- 32256
- Country
- US
- Correspondent
- JEFFREY L AULL
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Scalpel, One-Piece | GDX | Class 1 | General, Plastic Surgery | No | 2014-10-15 |
| Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | KHJ | Class 2 | Ear, Nose, Throat | No | 2011-01-19 |
| Splint, Intranasal Septal | LYA | Class 1 | Ear, Nose, Throat | No | 2011-01-19 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2009-01-12 |
| Splint, Nasal | EPP | Class 1 | Ear, Nose, Throat | No | 1992-10-09 |
| Anti Fog Solution And Accessories, Endoscopy | OCT | Class 2 | Gastroenterology, Urology | No | 2011-01-19 |
| Button, Nasal Septal | LFB | Class U | Unknown | No | 2008-02-15 |
| Tube, Tympanostomy | ETD | Class 2 | Ear, Nose, Throat | No | 2008-02-15 |
| Tube, Tracheal (W/Wo Connector) | BTR | Class 2 | Anesthesiology | No | 2008-02-15 |
| Knife, Nasal | KAS | Class 1 | Ear, Nose, Throat | No | 1992-10-09 |
| Hook, Microsurgical Ear | JYL | Class 1 | Ear, Nose, Throat | No | 2015-03-05 |
| Tube, Tonsil Suction | KCB | Class 1 | Ear, Nose, Throat | No | 2015-03-05 |
| Knife, Ent | KTG | Class 1 | Ear, Nose, Throat | No | 2021-06-24 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2013-11-13 |
| Prosthesis, Partial Ossicular Replacement | ETB | Class 2 | Ear, Nose, Throat | No | 2022-06-29 |
| Replacement, Ossicular Prosthesis, Total | ETA | Class 2 | Ear, Nose, Throat | No | 2022-06-29 |
| Punch, Nasal | KAY | Class 1 | Ear, Nose, Throat | No | 1992-10-09 |
| Bur, Ear, Nose And Throat | EQJ | Class 1 | Ear, Nose, Throat | No | 2003-08-05 |
| Protector, Dental | BRW | Class 1 | Anesthesiology | No | 2017-01-25 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2014-03-12 |
| Tube, Ear Suction | JZF | Class 1 | Ear, Nose, Throat | No | 2008-02-18 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 1992-10-09 |
| Applicator, Ent | KCJ | Class 1 | Ear, Nose, Throat | No | 2024-10-09 |
| Balloon, Epistaxis | EMX | Class 1 | Ear, Nose, Throat | No | 1992-10-09 |
| Cement, Ear, Nose And Throat | NEA | Class 2 | Dental | No | 2011-01-19 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2017-11-27 |
| Blower, Powder, Ent | KCL | Class 1 | Ear, Nose, Throat | No | 2015-03-05 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 1992-10-09 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2020-12-08 |
| Curette, Nasal | KAP | Class 1 | Ear, Nose, Throat | No | 1992-10-09 |
| Sponge, Ophthalmic | HOZ | Class 2 | Ophthalmic | No | 2018-06-12 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2012-09-05 |
| Scissors, Nasal | KBD | Class 1 | Ear, Nose, Throat | No | 1992-10-09 |
| Device, Inflation, Middle Ear | MJV | Class U | Unknown | No | 2014-07-07 |
Proprietary Names
Blades
Gelita-Spon Absorable Gelatin Sponge Hemostat
Clearview Endoscope Cover
Invotec Internal Nasal Splint
AntiFog
Invotec Septal Button
Invotec Ventilation Tubes
Invotec Tracheal T-Tube
NASAL SICKEL KNIFE
Invotec Ear Hook
Invotec Tonsil Cannula
Invotec ENT Blades
Invotec Laryngeal Electrode
Audio Technologies Middle Ear Implants Total and Partials
NASAL PUNCH
Spiggle and Theis Ossicular Replacement
NOSE
BUR#EAR
AND THROAT
Invotec Mouth Guard
PVA Nasal Tampons
PVA Nasal Packs
Mediplast Suction Tube
SWISS THERAPY
Invotec Phenol Applicator Kit
POST-STAT
QUICK-PACIC
ULTRA-STAT
SerenoCem Otologic Bone Cement
Invotec Ear Protector Kit
Kabierske Powder Blower
Invotec Nasal Forcepts
Swiss Therapy Eye Mask
Disposable Monopolar Direct Nerve Stimulator Probe
Disposable Hook Nerve Probe
Disposable Direct Concentric Nerve Stimulator Probe
Disposable Flush Tip Direct Tip Nerve Stimulator Probe
Disposable Ball Tip Direct Nerve Stimulator Probe
Disposable Bipolar Direct Nerve Stimulator Probe
Invotec Nasal Curette
Invotec Eye Spears
Invotec Silicone Tubing
NASAL SCISSORS
Otovent AutoInflation Kit
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device