Fresenius Medical Care North America

Fresenius Medical Care North America — FDA 510(k) Submissions

Fresenius Medical Care North America has submitted 43 FDA 510(k) premarket notifications since 1998, of which 43 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, Set, Tubing, Blood, With And Without Anti-regurgitation Valve, Set, Administration, For Peritoneal Dialysis, Disposable, Dialysate Concentrate For Hemodialysis (liquid Or Powder), Accessories, Blood Circuit, Hemodialysis . Use the specialty filter in the sidebar to narrow results.