Invotec International, Inc.
Jacksonville, FL, US
INVOTEC INTERNATIONAL, INC. appears in FDA device records in Jacksonville, FL. FDA records list 16 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 16 510(k) clearances for Invotec International, Inc. between 1990 and 2013. The busiest year on record is 1990, with 6. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 6 |
| 1991 | 3 |
| 1993 | 1 |
| 1997 | 3 |
| 2003 | 1 |
| 2008 | 1 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K122040 | INVOTEC LARYNGEAL ELECTRODE | ETN | Substantially Equivalent | |
| K080740 | CLEARVIEW ENDOSCOPE COVER | EOB | Substantially Equivalent | |
| K030492 | TITANIUM OSSICULAR REPLACMENT SYSTEM | ETA | Substantially Equivalent | |
| K973580 | INVOTEC CLEAN PAD | EFQ | Substantially Equivalent | |
| K973578 | INVOTEC EAR TAMPON (WICK) W/STRING | KCN | Substantially Equivalent | |
| K971000 | EPISTAXIS NASAL PACK | EMX | Substantially Equivalent | |
| K930114 | TRACHEOSTOMY T-TUBE | BTR | Substantially Equivalent | |
| K911041 | INVOTEC X-RAY CASSETTE EQUIPMENT DRAPE | IXA | Substantially Equivalent | |
| K911040 | INVOTEC MICROSCOPE DRAPE | HMW | Substantially Equivalent | |
| K911039 | INVOTEC EAR DRAPE | KKX | Substantially Equivalent | |
| K901923 | INVOTEC POLY-MESH MANDIBULAR TRAY | JAZ | Substantially Equivalent | |
| K903285 | MICRO BRIGHT VENTILATION TUBES | ETD | Substantially Equivalent | |
| K901366 | INVOTEC SEPTAL BUTTON | LFB | Substantially Equivalent | |
| K901310 | ULTRASTAT NASAL CATHETER | EMX | Substantially Equivalent | |
| K901307 | PASSAGE AIRWAY SPLINT | LYA | Substantially Equivalent | |
| K901306 | INVOTEC BI-VALVE SPLINT | LYA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1052728 | 1000113735 | INVOTEC INTERNATIONAL, INC. | 6833 PHILLIPS INDUSTRIAL BLVD., Jacksonville, FL 32256 US | 2026 | and 24 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- OCTAnti Fog Solution And Accessories, Endoscopy
- KCJApplicator, Ent
- EMXBalloon, Epistaxis
- KCLBlower, Powder, Ent
- EQJBur, Ear, Nose And Throat
- LFBButton, Nasal Septal
- IXACassette, Radiographic Film
- NEACement, Ear, Nose And Throat
- KAPCurette, Nasal
- MJVDevice, Inflation, Middle Ear
- HMWDrape, Microscope, Ophthalmic
- KKXDrape, Surgical, Antimicrobial
- NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic
- NADDressing, Wound, Occlusive
- KCNEar Wick
- KAEForceps, Ent
- NABGauze / Sponge,Nonresorbable For External Use
- EFQGauze/Sponge, Internal
- JYLHook, Microsurgical Ear
- KTGKnife, Ent
- KASKnife, Nasal
- EOBNasopharyngoscope (Flexible Or Rigid)
- IMEPack, Hot Or Cold, Reusable
- KHJPolymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
- JAZProsthesis, Facial, Mandibular Implant
- ETBProsthesis, Partial Ossicular Replacement
- BRWProtector, Dental
- KAYPunch, Nasal
- ETAReplacement, Ossicular Prosthesis, Total
- GDXScalpel, One-Piece
- KBDScissors, Nasal
- LYASplint, Intranasal Septal
- EPPSplint, Nasal
- HOZSponge, Ophthalmic
- ETNStimulator, Nerve
- JZFTube, Ear Suction
- KCBTube, Tonsil Suction
- BTRTube, Tracheal (W/Wo Connector)
- ETDTube, Tympanostomy
- GAZTubing, Noninvasive
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain