Gambro Healthcare

Gambro Healthcare — FDA 510(k) Submissions

Gambro Healthcare has submitted 13 FDA 510(k) premarket notifications since 1996, of which 13 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Dialyzer, High Permeability With Or Without Sealed Dialysate System, Subsystem, Water Purification, System, Dialysate Delivery, Sorbent Regenerated, Bandage, Liquid, Conductivity Rate, Urea Nitrogen . Use the specialty filter in the sidebar to narrow results.