Medical Device Manufacturer · US , Hudson , NH

Kaneka Pharma America, LLC

4 submissions · 4 cleared · Since 2010
4
Total
4
Cleared
0
Denied

Kaneka Pharma America, LLC — FDA 510(k) Submissions

Kaneka Pharma America, LLC has submitted 4 FDA 510(k) premarket notifications since 2010, of which 4 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Aspiration Thrombectomy Catheter, Lacrimal Stents And Intubation Sets, Device, Neurovascular Embolization . Use the specialty filter in the sidebar to narrow results.

4 devices
1–4 of 4
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