Tusker Medical Inc

FDA Filings

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

FDA Registration(s)

Registration Number	3012130335
FEI Number	3012130335
Name	Tusker Medical Inc.
Owner & Operator	Smith & Nephew, Inc.
Contact Address	7135 Goodlett Farms Parkway Cordova TN 38016 US
Official Correspondent	Beth Zis x-978-7491260-x
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	155 Jefferson Dr Menlo Park, CA 94025 US
Establishment Type	Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMA P190016S003 Tusker Medical, Inc.	Tula System	2021-09-08
PMA P190016S002 Tusker Medical, Inc.	Tula System	2020-12-30
PMA P190016S001 Tusker Medical, Inc.	Tula SystemTube Delivery System (TDS)	2020-05-06
PMN P190016 \| QJA Tusker Medical Inc. [Smith & Nephew, Inc.]	Tympanostomy Tube Delivery System	2020-03-12
PMA P190016 Tusker Medical, Inc.	Tula® System	2019-11-25

Similar & Related FDA Registered Companies

Tusker Medical, Inc.155 Jefferson Drive, Suite 200menlo Park, CA 94025 PMA NumberP190016 Supplement NumberS006 Date Received09/22/2022 Decision Date12/15/2022 Product Code QJA Advisory Committee Ear Nose & Throat Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
Tusker Medical, Inc.155 Jefferson Drive, Suite 200menlo Park, CA 94025 PMA NumberP190016 Supplement NumberS005 Date Received08/24/2022 Decision Date09/22/2022 Product Code QJA Advisory Committee Ear Nose & Throat Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

SEC

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Tusker Medical, Inc. of CA

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2019031828577	Yantian,China (Mainland) -> Oakland, California	TRAY INSERT FOR UNILATERAL TULA KIT TRAY INSERT FOR BILATERIAL TULA KIT 2PKGS=18CTNS=4044PCS	18 CTN