Outset Medical Inc

FDA Filings

This page includes the latest FDA filings for Outset 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 Number3010355846
FEI Number3010355846
NameOutset Medical, Inc.
Owner & OperatorOutset Medical, Inc.
Contact Address3052 Orchard Drive
San Jose CA 95134 US
Official Correspondent
  • Jennifer Mascioli-Tudor
  • 001-669-2318235-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address3052 Orchard Drive
San Jose, CA 95134 US
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device
Company
DeviceDate
OUTSET MEDICAL, INC.
 Tablo(R) Cartridge PN-00042202024-05-29
OUTSET MEDICAL, INC.
 TabloCart™ with Prefiltration Drawer 2024-05-27
OUTSET MEDICAL, INC.
 TabloCart™ with Prefiltration Drawer 2024-05-27
OUTSET MEDICAL, INC.
 Tablo(R) Hemodialysis System 2024-05-07
OUTSET MEDICAL, INC.
 Tablo(R) Cartridge PN-00042202024-01-30
Outset Medical, Inc.
Tablo Hemodialysis System2022-07-29
Outset Medical, Inc.
Tablo Cartridge2021-11-26
OUTSET MEDICAL, INC.
 Tablo(R) Straws PN-0004467, PN-00054512020-08-11
OUTSET MEDICAL, INC.
 Tablo(R) Straws 2020-08-11
OUTSET MEDICAL, INC.
 Tablo(R) Disinfectant Straws PN-00046752020-08-11
OUTSET MEDICAL, INC.
 Tablo Hemodialysis Concentrate A-1252020-08-11
Outset Medical, Inc.
Tablo Hemodialysis System2020-03-31
Outset Medical, Inc.
Tablo? Straws2020-01-08
Outset Medical, Inc.
Tablo? Script2020-01-08
Outset Medical, Inc.
Tablo? Hemodialysis System2020-01-08
Outset Medical, Inc.
Tablo? Cartridge2020-01-08
Outset Medical, Inc.
Tablo? Straws2020-01-08
Outset Medical, Inc.
Tablo? Script2020-01-08
Outset Medical, Inc.
Tablo? Hemodialysis System2020-01-08
Outset Medical, Inc.
Tablo? Cartridge2020-01-08
Outset Medical, Inc.
Tablo? Straws2020-01-08
Outset Medical, Inc.
Tablo? Script2020-01-08
Outset Medical, Inc.
Tablo? Hemodialysis System2020-01-08
Outset Medical, Inc.
Tablo? Cartridge2020-01-08
Outset Medical, Inc.
Tablo? Straws2020-01-08
Outset Medical, Inc.
Tablo? Script2020-01-08
Outset Medical, Inc.
Tablo? Console2020-01-08
Outset Medical, Inc.
Tablo? Straws2020-01-08
Outset Medical, Inc.
Tablo? Script2020-01-08
Outset Medical, Inc.
Tablo? Console2020-01-08
Outset Medical, Inc.
Tablo Hemodialysis System, Tablo Cartridge2019-12-12
OUTSET MEDICAL, INC.
 Tablo Cartridge CART-2002019-06-07
OUTSET MEDICAL, INC.
 Tablo(R) Cartridge CART-3012019-06-07
OUTSET MEDICAL, INC.
 Tablo Needleless Cartridge, B CART-2012019-06-07
OUTSET MEDICAL, INC.
 Tablo Cartridge CART-1002019-06-07
OUTSET MEDICAL, INC.
 Tablo(R) Hemodialysis System PN-00030002019-02-21
OUTSET MEDICAL, INC.
 Tablo Straws ST-1002019-02-13
OUTSET MEDICAL, INC.
 Tablo Hemodialysis Concentrate A-3252019-02-13
OUTSET MEDICAL, INC.
 Tablo Hemodialysis Concentrate A-2252019-02-13
OUTSET MEDICAL, INC.
 Tablo Hemodialysis Concentrate B-1002019-02-13
OUTSET MEDICAL, INC.
 Tablo Hemodialysis Console 2019-02-13
OUTSET MEDICAL, INC.
Tablo Console2016-11-15
Outset Medical, Inc.
Tablo Cartridge2014-09-11

Related Finance Registrations
NCAGE Code5LLN1OUTSET MEDICAL, INC.!DBA HD+
CAGE Code5LLN1OUTSET MEDICAL, INC. HD+
S.A.M. Registration5LLN1 [788744477]OUTSET MEDICAL, INC. HD+
SEC0001484612Outset Medical, Inc. of DELAWARE
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020090434767Laem Chabang,Thailand -> Long Beach, CaliforniaMEDICAL SUPPLIES963 CTN
2020090434767Laem Chabang,Thailand -> Long Beach, CaliforniaMEDICAL SUPPLIES963 CTN
2020090336926Laem Chabang,Thailand -> Long Beach, CaliforniaMEDICAL SUPPLIES963 CTN
2020090336926Laem Chabang,Thailand -> Long Beach, CaliforniaMEDICAL SUPPLIES963 CTN
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