Gambro, Inc.

Gambro, Inc. — FDA 510(k) Submissions

Gambro, Inc. has submitted 86 FDA 510(k) premarket notifications since 1976, of which 86 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, Dialyzer, Capillary, Hollow Fiber, Accessories, Blood Circuit, Hemodialysis, Dialyzer, Parallel Flow, System, Dialysate Delivery, Single Patient . Use the specialty filter in the sidebar to narrow results.