FLOWONIX MEDICAL, INC

FDA Filings

This page includes the latest FDA filings for FLOWONIX MEDICAL, INC. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate

Latest Premarket Applications

PMAManufacturerDevice NameDate
FLOWONIX MEDICAL, INC.
Prometra Programmable Infusion Pump System, Pump Firmware Patch 0.282019-10-22
FLOWONIX MEDICAL, INC.
Prometra Programmable Infusion Pump System2019-09-23
FLOWONIX MEDICAL, INC.
Prometra II Programmable Infusuin Pump System2019-08-07
FLOWONIX MEDICAL, INC.
Prometra Programmable Infusion Pump System2019-07-03
FLOWONIX MEDICAL, INC.
Prometra Programmable Infusion Pump System2019-03-07
FLOWONIX MEDICAL, INC.
Prometra Programmable Infusion Pump System2019-01-31
FLOWONIX MEDICAL, INC.
Prometra Programmable Infusion Pump System2019-01-28
FLOWONIX MEDICAL, INC.
Prometra Programmable Infusion Pump System2018-12-17
FLOWONIX MEDICAL, INC.
Prometra Programmable Infusion Pump System2018-08-17
FLOWONIX MEDICAL, INC.
Prometra Programmable Implantable Pump / Prometra II Programmable Implantable Pump2017-12-19
FLOWONIX MEDICAL, INC.
Prometra Programmable Infusion Pump System2017-09-11
FLOWONIX MEDICAL, INC.
Prometra Programmable Infusion Pump System2017-08-21
FLOWONIX MEDICAL, INC.
Prometra Programmable Infusion Pump System2017-07-21
FLOWONIX MEDICAL, INC.
Prometra Programmable Infusion Pump System2017-06-29
FLOWONIX MEDICAL, INC.
Prometra Programmable Infusion Pump System2017-06-07
FLOWONIX MEDICAL, INC.
Prometra Programmable Infusion Pump System2017-05-31
FLOWONIX MEDICAL, INC.
PROMETRA PATIENT THERAPY CONTROLLER2017-03-31
FLOWONIX MEDICAL, INC.
Prometra Programmable Infusion Pump System2017-03-30
FLOWONIX MEDICAL, INC.
PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM CLINICIAN PROGRAMMER2016-12-16
FLOWONIX MEDICAL, INC.
PROMETRA PROGRAMMABLE IMPLANTABLE PUMP2016-08-31
FLOWONIX MEDICAL, INC.
PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM2016-05-26
FLOWONIX MEDICAL, INC.
PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM2016-01-12
FLOWONIX MEDICAL, INC.
PROMETRA PROGRAMMABLE PUMP SYSTEM2015-12-28
FLOWONIX MEDICAL, INC.
PROMETRA PROGRAMMABLE IMPLANTABLE PUMP2015-11-24
FLOWONIX MEDICAL, INC.
PROMETRA PROGRAMMABLE IMPLANTABLE PUMP2015-09-01
FLOWONIX MEDICAL, INC.
PROMETRA PROGRAMMABLE IMPLANTABLE PUMP2015-07-31
FLOWONIX MEDICAL, INC.
PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM2015-07-29
FLOWONIX MEDICAL, INC.
PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM2015-04-08
FLOWONIX MEDICAL, INC.
PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM2015-02-12
FLOWONIX MEDICAL, INC.
PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM2015-02-10

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
Prometra II Pump
Flowonix Medical, Inc.2018-10-22
Prometra Programmable Pump
Flowonix Medical, Inc.2018-10-22
Prometra Physician Configuration Device
Flowonix Medical, Inc.2018-07-06
Prometra Patient Therapy Controller
Flowonix Medical, Inc.2018-07-06
Prometra Programmer
Flowonix Medical, Inc.2018-07-06
Prometra Tunneler
Flowonix Medical, Inc.2018-07-06
Prometra Refill Kit
Flowonix Medical, Inc.2018-07-06
Prometra Catheter Access Kit
Flowonix Medical, Inc.2018-07-06
Prometra Programmer
Flowonix Medical, Inc.2018-07-06
Prometra Catheter Revision Kit
Flowonix Medical, Inc.2018-07-06
Prometra Intrathecal Catheter
Flowonix Medical, Inc.2018-07-06

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