Alphamed, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Alphamed, Inc. makes
Alphamed, Inc. manufactures disposable surgical tools, including the ALPHAMED Surgical Spear (Model 70-5000) for ophthalmic procedures, dissolvable punctum plugs for tear retention in dry eye management, and a manual irrigation pump (EZ PUMP). The company also produces the ALPHAMED Gemini Sensor, a snoring sensor designed for monitoring respiratory patterns during sleep.
The company’s products are regulated under FDA classifications, including Class I, Class II, and unclassified (U) devices, with several authorised via the 510(k) pathway. The portfolio is listed in the FDA’s 510(k) database, and the manufacturer operates from the United States.
Catalogue
Alphamed Surgical Spear, Model 70-5000 Ref K091240
Regimes: 510(k) Registry: 510(k)Tear Pool Dissolvable Punctum Plugs Ref K190210
Regimes: 510(k) Registry: 510(k)Ez Pump Ref K926446
Regimes: 510(k) Registry: 510(k)Alphamed Gemini Sensor, Snoring Sensor Ref K990321
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Alphamed, Inc. have in the registry?
The registry currently lists 4 devices for Alphamed, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Alphamed, Inc.'s devices?
Among its 4 most recently registered devices, Alphamed, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Alphamed, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Alphamed, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Alphamed, Inc. in the registry?
The most recently registered devices listed for Alphamed, Inc. include ALPHAMED SURGICAL SPEAR, MODEL 70-5000, Tear Pool Dissolvable Punctum Plugs, EZ PUMP and ALPHAMED GEMINI SENSOR, SNORING SENSOR.