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Tube, Tympanostomy
FDA product code ETD · Class 2 · Ear, Nose, Throat
1,551
Registered devices
92
Adverse events
14
Recalls
116
510(k) clearances
Devices with this code
Armstrong — MEDTRONIC XOMED, INC.Paparella — MEDTRONIC XOMED, INC.Donaldson — MEDTRONIC XOMED, INC.Goode T-Tube® — MEDTRONIC XOMED, INC.Baxter — MEDTRONIC XOMED, INC.MICRON — Gyrus ACMI, LLCGYRUS ACMI — Gyrus ACMI, LLCSummit Medical — Summit Medical, Inc.Goode T-Tube® — MEDTRONIC XOMED, INC.STRAIGHT VENT TUBE — Grace Medical, Inc.Mortez — MEDTRONIC XOMED, INC.Shepard — MEDTRONIC XOMED, INC.GYRUS ACMI — Gyrus ACMI, LLCPAPARELLA VENT TUBE W/TAB — Grace Medical, Inc.Donaldson — MEDTRONIC XOMED, INC.Invotec Tympanostomy Tube — INVOTEC INTERNATIONAL, INC.Hubbard — MEDTRONIC XOMED, INC.NeoZoline — ADEPT MEDICAL LIMITEDC-Flex® — MEDTRONIC XOMED, INC.Paparella — MEDTRONIC XOMED, INC.Moretz Tytan® — MEDTRONIC XOMED, INC.NeoZoline — JEDMED INSTRUMENT COMPANYNA — Summit Medical, Inc.Microgel® — MEDTRONIC XOMED, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-11-24 | Adept Medical Ltd | Lack of 510(k) clearance. |
| 2024-11-24 | Adept Medical Ltd | Lack of 510(k) clearance. |
| 2024-11-24 | Adept Medical Ltd | Lack of 510(k) clearance. |
| 2024-11-24 | Adept Medical Ltd | Lack of 510(k) clearance. |
| 2024-11-24 | Adept Medical Ltd | Lack of 510(k) clearance. |
| 2024-11-24 | Adept Medical Ltd | Lack of 510(k) clearance. |
| 2024-11-24 | Adept Medical Ltd | Lack of 510(k) clearance. |
| 2024-11-24 | Adept Medical Ltd | Lack of 510(k) clearance. |
| 2024-11-19 | Olympus Corporation of the Americas | Potential that Duravent Silicone Ventilation Tubes may contain incorrect product, specifically, 1.32 mm Tiny T Tubes (model: 70240076) instead of the intended D |
| 2023-12-11 | Olympus Corporation of the Americas | The expiration date is missing from the primary (inner) packaging. The secondary (outer) box label correctly states the expiration date of February 12, 2033, fo |
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