Company ยท US
Invotec International, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 2013. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EMX | Balloon, Epistaxis | 2 |
| LYA | Splint, Intranasal Septal | 2 |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 |
| EFQ | Gauze/Sponge, Internal | 1 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 1 |
| ETA | Replacement, Ossicular Prosthesis, Total | 1 |
| ETD | Tube, Tympanostomy | 1 |
| ETN | Stimulator, Nerve | 1 |
| HMW | Drape, Microscope, Ophthalmic | 1 |
| IXA | Cassette, Radiographic Film | 1 |
| JAZ | Prosthesis, Facial, Mandibular Implant | 1 |
| KCN | Ear Wick | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 |
| LFB | Button, Nasal Septal | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 31, 2013 | K122040 | INVOTEC LARYNGEAL ELECTRODE Invotec International, Inc. | ETN |
| Dec 31, 2008 | K080740 | CLEARVIEW ENDOSCOPE COVER Invotec International, Inc. | EOB |
| Mar 3, 2003 | K030492 | TITANIUM OSSICULAR REPLACMENT SYSTEM Invotec International, Inc. | ETA |
| Dec 10, 1997 | K973580 | INVOTEC CLEAN PAD Invotec International, Inc. | EFQ |
| Nov 6, 1997 | K973578 | INVOTEC EAR TAMPON (WICK) W/STRING Invotec International, Inc. | KCN |
| May 14, 1997 | K971000 | EPISTAXIS NASAL PACK Invotec International, Inc. | EMX |
| Mar 19, 1993 | K930114 | TRACHEOSTOMY T-TUBE Invotec International, Inc. | BTR |
| Jun 4, 1991 | K911041 | INVOTEC X-RAY CASSETTE EQUIPMENT DRAPE Invotec International, Inc. | IXA |
| Jun 3, 1991 | K911040 | INVOTEC MICROSCOPE DRAPE Invotec International, Inc. | HMW |
| May 13, 1991 | K911039 | INVOTEC EAR DRAPE Invotec International, Inc. | KKX |
| Oct 31, 1990 | K901923 | INVOTEC POLY-MESH MANDIBULAR TRAY Invotec International, Inc. | JAZ |
| Sep 26, 1990 | K903285 | MICRO BRIGHT VENTILATION TUBES Invotec International, Inc. | ETD |
| Jun 14, 1990 | K901366 | INVOTEC SEPTAL BUTTON Invotec International, Inc. | LFB |
| Jun 14, 1990 | K901310 | ULTRASTAT NASAL CATHETER Invotec International, Inc. | EMX |
| Jun 14, 1990 | K901307 | PASSAGE AIRWAY SPLINT Invotec International, Inc. | LYA |
| Jun 14, 1990 | K901306 | INVOTEC BI-VALVE SPLINT Invotec International, Inc. | LYA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||