Saluda Medical Pty L T D

FDA Filings

This page includes the latest FDA filings for Saluda Medical Pty L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3012939358
FEI Number3012939358
NameSALUDA MEDICAL PTY LTD
Owner & OperatorSaluda Medical Pty Ltd
Contact Address407 Pacific Highway
Artarmon AU-NSW New South Wales 2064 AU
Official Correspondent
  • Parmjeet Gill
  • 61-2-84058-747
US Agent
Importing Logistics Registration
ImporterSALUDA MEDICAL AMERICAS INC
Address9401 James Ave S, Suite 132
Bloomington, MN 55431 UNITED STATES
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address407 Pacific Highway
Artarmon New South Wales, 2064 AU
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility



FDA Filings

Device
Company
DeviceDate
SALUDA MEDICAL PTY LIMITED
Evoke® 12C Percutaneous Trial Lead Kit - 90 cm 30172022-03-23
SALUDA MEDICAL PTY LIMITED
Evoke® 12C Lead Extension Kit - 55cm 30112022-03-23
SALUDA MEDICAL PTY LIMITED
Evoke® Accessory Belt 30392022-03-23
SALUDA MEDICAL PTY LIMITED
Evoke® Intraoperative Cable Kit 30342022-03-23
SALUDA MEDICAL PTY LIMITED
Evoke® eCLS Battery Charger Kit 30382022-03-23
SALUDA MEDICAL PTY LIMITED
Evoke® External Closed-Loop Stimulator (eCLS) 30362022-03-23
SALUDA MEDICAL PTY LIMITED
Evoke® External Closed-Loop Stimulator (eCLS) Case 30352022-03-23
SALUDA MEDICAL PTY LIMITED
Evoke® Closed-Loop Stimulator (CLS) 30022022-03-23
SALUDA MEDICAL PTY LIMITED
Evoke® Clinical Interface (CI) 30242022-03-23
SALUDA MEDICAL PTY LIMITED
Evoke® 12C Percutaneous Trial Lead Kit - 60 cm 30162022-03-23
SALUDA MEDICAL PTY LIMITED
Evoke® Spares Kit 30152022-03-23
SALUDA MEDICAL PTY LIMITED
Evoke® Epidural Needle 6.5" 30142022-03-23
SALUDA MEDICAL PTY LIMITED
Evoke® Tunnelling Tool 30122022-03-23
SALUDA MEDICAL PTY LIMITED
Evoke® 12C Percutaneous Lead Kit - 90 cm 30092022-03-23
SALUDA MEDICAL PTY LIMITED
Evoke® 12C Percutaneous Lead Kit - 60 cm 30082022-03-23
SALUDA MEDICAL PTY LIMITED
Evoke® Charger 30062022-03-23
SALUDA MEDICAL PTY LIMITED
Evoke® Clinical System Transceiver (CST) 30042022-03-23
SALUDA MEDICAL PTY LIMITED
Evoke® Pocket Console (EPC) 30402022-03-23
SALUDA MEDICAL PTY LTD
Evoke Tunneling Tool2019-11-14
SALUDA MEDICAL PTY LTD
Evoke Spares Kit2019-11-14
SALUDA MEDICAL PTY LTD
Evoke Lead Adapter Kit2019-11-14
SALUDA MEDICAL PTY LTD
Evoke Intraoperative Cable Kit2019-11-14
SALUDA MEDICAL PTY LTD
Evoke Epidural Needle, 6.5"2019-11-14
SALUDA MEDICAL PTY LTD
Evoke 12C Percutaneous Lead Kit - 90cm2019-11-14
SALUDA MEDICAL PTY LTD
Evoke 12C Percutaneous Lead Kit - 60cm2019-11-14
SALUDA MEDICAL PTY LTD
Evoke 12C Lead Extension Kit - 55cm2019-11-14

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