Augmenix Inc

FDA Filings

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

FDA Registration(s)
Registration Number3008550999
FEI Number3008550999
NameAUGMENIX, INC.
Owner & OperatorBoston Scientific Corporation
Contact Address300 Boston Scientific Way
Marlborough MA 01752 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address201 Burlington Road
Bedford, MA 01730 US
Establishment Type
  • Manufacture Device in the United States for Export Only
  • Manufacture Medical Device



FDA Filings

Device
Company
DeviceDate
AUGMENIX, INC.
SpaceOAR VUE™ System - 10mL SV-21012019-10-09
AUGMENIX, INC.
TraceIT Tissue Marker 3mL 5-UP TH-10352019-09-30
AUGMENIX, INC.
TraceIT Tissue Marker 5-UP TH-10152019-09-30
AUGMENIX, INC.
TraceIT Tissue Marker 3mL 1-UP TH-10312019-09-30
AUGMENIX, INC.
TraceIT Tissue Marker 1-UP TH-10112019-09-30
AUGMENIX, INC.
SpaceOAR System SO-21012019-09-30
Augmenix, Inc
SpaceOAR Vue Hydrogel2019-07-19
AUGMENIX, INC. [Boston Scientific Corporation]
TraceIT Gel System2018-11-02
AUGMENIX, INC. [Boston Scientific Corporation]
TraceIT Fiducial Marker2018-11-02
Augmenix, Inc.
SpaceOAR System2018-06-25
AUGMENIX, INC.
TraceIT Tissue Marker - 3mL2015-08-19
AUGMENIX , INC.
SpaceOAR System2015-04-01
AUGMENIX , INC.
MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML2013-01-23

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