Humboldt Products
Country not established
- Devices
- 5
What Humboldt Products makes
Humboldt Products manufactures single-use and reusable otological instruments, including myringotomy disposable kits, ventilation tubes for ear drainage, and surgical retractors with elastic stays. Their portfolio also includes stainless steel pistons for medical devices and the Drumto stapes prosthesis, a surgical implant for inner ear reconstruction.
The company’s products are regulated under FDA Class I and Class II classifications, with several devices authorised via the 510(k) pathway. These items are listed in the FDA’s 510(k) registry, and the manufacturer operates from the United States.
Catalogue
Tekna Med Myringotomy Dispos-Oto Kit Ref K813616
Regimes: 510(k) Registry: 510(k)Otological Ventilation Tubes Ref K802587
Regimes: 510(k) Registry: 510(k)Surgical Retractor & Elastic Stays, Disp Ref K812562
Regimes: 510(k) Registry: 510(k)Stainless Steel Pistons Ref K823483
Regimes: 510(k) Registry: 510(k)Drumto Stapes Prosthesis Ref K832540
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Humboldt Products have in the registry?
The registry currently lists 5 devices for Humboldt Products. Devices recorded under merged duplicate company entries are counted once.
Which registries list Humboldt Products's devices?
Among its 5 most recently registered devices, Humboldt Products has devices listed in FDA 510(k) (5 devices).
What risk classes do Humboldt Products's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Humboldt Products's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Humboldt Products in the registry?
The most recently registered devices listed for Humboldt Products include TEKNA MED MYRINGOTOMY DISPOS-OTO KIT, OTOLOGICAL VENTILATION TUBES, SURGICAL RETRACTOR & ELASTIC STAYS, DISP and STAINLESS STEEL PISTONS.