Proto-Med, Inc.
United StatesFDA applicant, unverified FDA
- Devices
- 6
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Proto-Med, Inc. makes
Proto-Med, Inc. manufactures tools for intrauterine device (IUD) retrieval, including the Emmett IUD Thread Retriever, designed for removing IUD threads, and portable oxygen concentrators such as the Royal 1 and Generic Oxygen Concentrator.
The company’s products are regulated under FDA Class I and Class II classifications, with oxygen concentrators and retrieval tools listed via the 510(k) pathway. These devices are based in the United States.
Catalogue
DigiGuide System Ref K193499
Regimes: 510(k) Registry: 510(k)The Emmett Iud Thread Retriever Ref K811761
Regimes: 510(k) Registry: 510(k)Emmett Iud Thread Retreiver Ref K820115
Regimes: 510(k) Registry: 510(k)Royal 1 Oxygen Concentrator Ref K822301
Regimes: 510(k) Registry: 510(k)Protomed/Towic Nasogastric Tube Drainage Bag Ref K841986
Regimes: 510(k) Registry: 510(k)The Generic Oxygen Concentrator Ref K844852
Regimes: 510(k) Registry: 510(k)
FDA establishments
- Protomed SA FR
Frequently asked questions
How many devices does Proto-Med, Inc. have in the registry?
The registry currently lists 6 devices for Proto-Med, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Proto-Med, Inc.'s devices?
Among its 6 most recently registered devices, Proto-Med, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Proto-Med, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Proto-Med, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Proto-Med, Inc. in the registry?
The most recently registered devices listed for Proto-Med, Inc. include DigiGuide System, THE EMMETT IUD THREAD RETRIEVER, EMMETT IUD THREAD RETREIVER and ROYAL 1 OXYGEN CONCENTRATOR.
Which FDA establishments are linked to Proto-Med, Inc.?
1 FDA establishment is linked to Proto-Med, Inc. in the registry; they are listed on the company page.