Medical Device Manufacturer · US , Duluth , GA

Alphamed, Inc.

4 submissions · 4 cleared · Since 1993

Total

Cleared

Denied

Alphamed, Inc. — FDA 510(k) Submissions

Alphamed, Inc. has submitted 4 FDA 510(k) premarket notifications since 1993, of which 4 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Sponge, Ophthalmic, Plug, Punctum, Scale, Patient, Ventilatory Effort Recorder . Use the specialty filter in the sidebar to narrow results.

4 devices

1–4 of 4

Tear Pool Dissolvable Punctum Plugs

K190210 · LZU Plug, Punctum · Ophthalmic

Oct 2019 262d

ALPHAMED SURGICAL SPEAR, MODEL 70-5000

K091240 · HOZ Sponge, Ophthalmic · Ophthalmic

Oct 2009 179d

ALPHAMED GEMINI SENSOR, SNORING SENSOR

K990321 · MNR Ventilatory Effort Recorder · Anesthesiology

Jun 1999 120d

EZ PUMP