Northwell Health

FDA Filings

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

FDA Registration(s)
Registration Number3015146876
FEI Number3015146876
NameNORTHWELL HEALTH
Owner & OperatorNorthwell Health
Contact Address600 Community Dr
Manhasset NY 11030 US
Official Correspondent
  • Todd Goldstein
  • 1-516-3218092-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address600 Community Dr
Manhasset, NY 11030 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device

FDA Filings

Device
Company
DeviceDate
NORTHWELL HEALTH
Retainer2018-11-12
NORTHWELL HEALTH
Dental stent2018-11-12
NORTHWELL HEALTH
The Fin2018-11-06

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U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2018061157370Anvers,Belgium -> Baltimore, MarylandDIAGNOSTIC INVITRO HS:84799015 PKG
2018053171437Anvers,Belgium -> New York/Newark Area, Newark, New JerseyDIAGNOSTIC INVITRO HS:84799018 PKG
2018053171437Anvers,Belgium -> New York/Newark Area, Newark, New JerseyDIAGNOSTIC INVITRO HS:84799018 PKG
2018053174759Anvers,Belgium -> New York/Newark Area, Newark, New JerseyDIAGNOSTIC INVITRO HS:84799013 PKG
2018053082327Anvers,Belgium -> New York/Newark Area, Newark, New JerseyDIAGNOSTIC INVITRO HS:8479905 PKG
2018053086543Anvers,Belgium -> New York/Newark Area, Newark, New JerseyDIAGNOSTIC INVITRO HS:84799013 PKG
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