Stryker Ent

FDA Filings

This page includes the latest FDA filings for Stryker Ent. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Filings

Device Company	Device	Date
PMN K201398 Stryker ENT	SINUSPRIME Dilation System	2020-10-15
PMN K193118 Stryker ENT	TGS Guidewire And Updated Scopis Software	2020-02-21
PMN K193502 Stryker ENT	TGS Universal Headrest With Mounting Arm	2020-02-14

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• Stryker Neurovascular47900 Bayside Parkwayfremont, CA 94538 PMA NumberP180031 Supplement NumberS005 Date Received09/20/2022 Decision Date11/15/2022 Product Code QCA  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No