Endologix Inc

FDA Filings

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

USANASDAQELGXDUNS 858560477

Endologix Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3008011247
FEI Number3008011247
NameEndologix, Inc.
Owner & OperatorEndologix, Inc.
Contact Address2 MUSICK
Irvine CA 92618 US
Official Correspondent
  • Mirna Hassoun
  • 1-949-5984679-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address3910 Brickway Blvd
Santa Rosa, CA 95403 US
Establishment Type
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198



Registration Number3013162347
FEI Number3013162347
NameEndologix International Holdings B.V.
Owner & OperatorEndologix, Inc.
Contact Address2 MUSICK
Irvine CA 92618 US
Official Correspondent
  • Mirna Hassoun
  • 1-949-5984679-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressEuropalaan 30
Hertogenbosch Noord-Brabant, 5232 BC's NL
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility



Registration Number3011063223
FEI Number3011063223
NameENDOLOGIX, INC.
Owner & OperatorEndologix, Inc.
Contact Address2 MUSICK
Irvine CA 92618 US
Official Correspondent
  • Mirna Hassoun
  • 1-949-5984679-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2 Musick
Irvine, CA 92618 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-EX121245-J2023-07-19
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-IL1414100-J2023-03-13
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-IL1412160-J2023-03-13
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-IL1414120-J2023-03-13
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-IL1412140-J2023-03-13
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-IL1412120-J2023-03-13
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-IL1412100-J2023-03-13
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-IL141280-J2023-03-13
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-IL141080-J2023-03-10
Endologix, Inc.
CustomSeal Kit TV-CS14-G2023-03-10
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-IL1416160-J2023-03-10
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-IL1414160-J2023-03-10
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-IL1418160-J2023-03-10
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-IL142880-J2023-03-10
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-IL1422160-J2023-03-10
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-IL1422140-J2023-03-10
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-IL1422120-J2023-03-10
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-IL1422100-J2023-03-10
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-IL142280-J2023-03-10
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-IL1418140-J2023-03-10
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-IL1418120-J2023-03-10
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-IL1418100-J2023-03-10
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-IL141880-J2023-03-10
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-IL1416140-J2023-03-10
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-IL1416120-J2023-03-10
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-IL1416100-J2023-03-10
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-IL141680-J2023-03-10
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-IL1414140-J2023-03-10
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-IL1428100-J2023-03-10
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-IL1428120-J2023-03-10
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-IL1410140-J2023-03-10
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-IL1410120-J2023-03-10
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-IL1410100-J2023-03-10
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-IL1410160-J2023-03-10
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-IL141480-J2023-03-10
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-IL1428140-J2023-03-10
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-EX282845-J2023-03-10
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-IL1428160-J2023-03-10
Endologix, Inc.
Alto™ Abdominal Stent Graft System TV-AB3480-N2023-03-08
Endologix, Inc.
Alto™ Abdominal Stent Graft System TV-AB2980-N2023-03-08
Endologix, Inc.
Alto™ Abdominal Stent Graft System TV-AB2680-N2023-03-08
Endologix, Inc.
Alto™ Abdominal Stent Graft System TV-AB2380-N2023-03-08
Endologix, Inc.
Autoinjector 2 TV-AI01-N2023-03-08
Endologix, Inc.
Alto™ Abdominal Stent Graft System TV-AB2080-N2023-03-08
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-EX222245-J2023-03-08
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-EX181845-J2023-03-08
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-EX161645-J2023-03-08
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-EX141445-J2023-03-08
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-EX101045-J2023-03-08
Endologix, Inc.
Ovation iX Iliac Stent Graft TV-EX121245-J2023-03-08
ENDOLOGIX, INC.
Autoinjector 2 TV-AI01-N2020-12-21
ENDOLOGIX, INC.
Alto™ Abdominal Stent Graft System TV-AB3480-N2020-12-21
ENDOLOGIX, INC.
Alto™ Abdominal Stent Graft System TV-AB2980-N2020-12-21
ENDOLOGIX, INC.
Alto™ Abdominal Stent Graft System TV-AB2680-N2020-12-21
ENDOLOGIX, INC.
Alto™ Abdominal Stent Graft System TV-AB2380-N2020-12-21
ENDOLOGIX, INC.
Alto™ Abdominal Stent Graft System TV-AB2080-N2020-12-21
ENDOLOGIX, INC.
AFX Endovascular AAA System2020-08-05
ENDOLOGIX, INC.
AFX Endovascular AAA System2020-07-23
Endologix, Inc.
Ovation iX Abdominal Stent Graft System2020-07-09
Endologix, Inc.
Alto Abdominal Stent Graft System2020-06-16
Endologix, Inc.
Alto Abdominal Stent Graft System2020-04-24
ENDOLOGIX, INC.
AFX Introducer System 2020-03-05
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System 2019-09-04
ENDOLOGIX, INC.
AFX Endovascular AAA System2019-08-16
Endologix, Inc.
Ovation iX Iliac Stent Graft2018-11-14
Endologix, Inc.
Ovation iX Abdominal Stent Graft System2018-11-14
Endologix, Inc.
Ovation Prime Abdominal Stent Graft System2018-11-14
Endologix, Inc.
Ovation Abdominal Stent Graft System2018-11-14
Endologix, Inc.
Alto Abdominal Stent Graft System2018-11-14
Endologix, Inc.
Ovation Stent Graft System2018-11-14
ENDOLOGIX, INC.
AFX Endovascular AAA System2018-08-09
ENDOLOGIX, INC.
AFX Endovascular AAA System2018-07-03
ENDOLOGIX, INC.
Endologix Powerlink System2017-06-02
ENDOLOGIX, INC.
AFX Endovascular AAA System2017-05-02
ENDOLOGIX, INC.
AFX ENDOVASCULAR AAA SYSTEM2015-12-02
ENDOLOGIX, INC.
AFX ENDOVASCULAR AAA STENT SYSTEM2015-11-18
ENDOLOGIX, INC.
AFX ENDOVASCULAR AAA SYSTEM2015-10-07
ENDOLOGIX, INC.
AFX ENDOVASCULAR AAA SYSTEM2015-06-17
ENDOLOGIX, INC.
AFX ENDOVASCULAR AAA SYSTEM2014-12-31
ENDOLOGIX, INC.
AFX VELA PROXIMAL ENDOGRAFT SYSTEM2014-08-12
ENDOLOGIX, INC.
AFX ENDOVASCULAR AAA SYSTEM (ACCESSORY STENT GRAFT DELIVERY SYSTEM2014-07-30
ENDOLOGIX, INC.
AFX BIFURCATED STENT GRAFT DELIVERY SYSTEM2014-07-14
ENDOLOGIX, INC.
AFX ENDOVASCULAR AAA SYSTEM2014-07-11
ENDOLOGIX, INC.
AFX ENDOVASULAR AAA SYSTEM2014-07-09
ENDOLOGIX, INC.
AFX ENDOVASCULAR AAA SYSTEM2014-07-07
ENDOLOGIX, INC.
AFX ENDOVASCULAR AAA SYSTEM2014-06-18
ENDOLOGIX, INC.
AFX ENDOVASCULAR AAA SYSTEM2014-02-06
ENDOLOGIX, INC.
AFX VELA PROXIMAL ENDOGRAFT DELIVERY SYSTEM2014-01-24
ENDOLOGIX, INC.
AFX ENDOVASCULAR AAA DELIVERY SYSTEM2013-08-26
ENDOLOGIX, INC.
AFX ENDOVASCULAR AAA SYSTEM2013-08-12
ENDOLOGIX, INC.
AFX ENDOVASCULAR AAA SYSTEM2013-06-17
ENDOLOGIX, INC.
POWERLINK SYSTEM WITH INTUITRAK DELIVERY SYSTEM2013-04-16
ENDOLOGIX, INC.
AFX ENDOVASCULAR AAA SYSTEM2012-12-28
ENDOLOGIX, INC.
AFX STAND-ALONE LIMB EXTENSION DELIVERY SYSTEM2012-08-22
ENDOLOGIX, INC.
AFX ENDOVASCULAR AAA SYSTEM2012-06-01
Endologix International Holdings B.V. [Endologix, Inc.]
AFX Introducer System2012-04-18
ENDOLOGIX, INC.
AFX Introducer System2012-04-18
ENDOLOGIX, INC.
AFX ENDOVASCULAR AAA SYSTEM2012-02-15
ENDOLOGIX, INC.
AFX INTRODUCER SYSTEM2012-02-09
ENDOLOGIX, INC.
AFX ENDOVASCULAR AAA SYSTEM2011-12-06
ENDOLOGIX, INC.
ENDOLUMINAL PROSTHESIS2011-11-04
ENDOLOGIX, INC.
AFX ACCESSORY STENT GRAFT DELIVERY SYSTEMS2011-09-29
ENDOLOGIX, INC.
ENDOLOGIX AFX INTRODUCER SYSTEM2011-07-12
ENDOLOGIX, INC.
POWERLINK WITH INTUITRAK DELIVERY SYSTEM2011-06-30
ENDOLOGIX, INC.
AFX INTRODUCER SYSTEM2011-05-26
ENDOLOGIX, INC.
AFX ENDOVASCULAR AAA SYSTEM2011-05-06
ENDOLOGIX, INC.
POWERLINK STENT GRAFT WITH 17FR. INTUITRAK ACCESSORY DELIVERY SYSTEM2011-01-20
ENDOLOGIX, INC.
POWERLINK STENT GRAFT WITH INTUITRAK DELIVERY SYSTEM2010-12-29
ENDOLOGIX, INC.
POWERLINK SYSTEM FOR AAA2010-07-28
ENDOLOGIX, INC.
POWERLINK STENT GRAFT WITH INTUITRAK DELIVERY SYSTEM2010-05-13
ENDOLOGIX, INC.
POWERLINK SYSTEMWITH INTUITRAK DELIVERY SYSTEM2010-05-12
ENDOLOGIX, INC.
POWERLINK SYSTEM WITH INTUITRAK DELIVERY SYSTEM2010-01-06
ENDOLOGIX, INC.
POWERLINK SYSTEM WITH INTUI TRAK DELIVERY SYSTEM2009-09-16
ENDOLOGIX, INC.
POWERLINK SYSTEM2009-04-17
ENDOLOGIX, INC.
POWERLINK SYSTEM2009-02-20
ENDOLOGIX, INC.
ENDOLOGIX, INC. POWERLINK SYSTEM2008-11-04
ENDOLOGIX, INC.
ENDOLOGIX POWERLINK SYSTEM, VISIFLEX IS DELIVERY SYSTEM2008-10-14
ENDOLOGIX, INC.
POWERLINK SYSTEM, 25MM, 28MM, AND 34MM SUPRARENAL BIFURCATED STENT GRAFTS AND ACCESSORIES2008-10-08
ENDOLOGIX, INC.
POWERLINK SYSTEM2008-08-27
ENDOLOGIX, INC.
POWERLINK SYSTEM VISIFLEX IS DELIVERY CATHETERS2008-06-12
ENDOLOGIX, INC.
ENDOLOGIX VISIFLEX DUAL LUMEN CATHETER2008-04-08
ENDOLOGIX, INC.
POWERLINK SYSTEM2008-03-21
ENDOLOGIX, INC.
POWERLINK SYSTEM WITH VISIFLEX DELIVERY CATHETER2008-03-05
ENDOLOGIX, INC.
POWERLINK SYSTEM ANEURYSM STENT GRAFT2008-02-21
Endologix International Holdings B.V. [Endologix, Inc.]
Powerlink System2007-12-06
Endologix International Holdings B.V. [Endologix, Inc.]
AFX Delivery System2007-12-06
ENDOLOGIX, INC.
Powerlink System2007-12-06
ENDOLOGIX, INC.
AFX Delivery System2007-12-06
Endologix International Holdings B.V. [Endologix, Inc.]
Dual Lumen Catheter2007-12-06
ENDOLOGIX, INC.
Dual Lumen Catheter2007-12-06
ENDOLOGIX, INC.
POWERLINK SYSTEM WITH VISIFLEX DELIVERY CATHETER SYSTEM2007-05-18
ENDOLOGIX, INC.
POWERLINK SYSTEM WITH VISIFLEX DELIVERY CATHETER SYSTEM2007-04-13
ENDOLOGIX, INC.
POWERLINK SYSTEM WITH VISIFLEX DELIVERY CATHETER SYSTEM2007-04-04
ENDOLOGIX, INC.
POWERLINK SYSTEM WITH VISIFLEX SUREPASS DELIVERY CATHETER SYSTEM2007-03-29
ENDOLOGIX, INC.
POWERLINK SYSTEM WITH VISIFLEX DELIVERY CATHETER2007-01-18
ENDOLOGIX, INC.
ENDOLOGIX POWERLINK SYSTEM2006-11-01
ENDOLOGIX, INC.
ENDOLOGIX POWERLINK SYSTEM2006-05-17
ENDOLOGIX, INC.
ENDOLOGIX POWERLINK STENT GRAFT DELIVERY SYSTEM2006-04-14
ENDOLOGIX, INC.
POWERLINK SYSTEM2006-02-08
ENDOLOGIX, INC.
POWERLINK SYSTEM2006-02-01
ENDOLOGIX, INC.
ENDOLOGIX POWERLINK SYSTEM2005-02-15
ENDOLOGIX, INC.
ENDOLOGIX POWERLINK SYSTEM2004-10-29
ENDOLOGIX, INC.
DUAL LUMEN CATHETER, MODEL DL-35-901999-10-28
ENDOLOGIX, INC.
GUARDIAN CORONARY BALLOON DILATATION PTCA CATHETER1998-05-19
ENDOLOGIX, INC.
LYNX CONTOUR CORONARY BALLOON DILATATION CATHETER(A NEW MODEL OF THE FACT CATHETER).1998-04-08
ENDOLOGIX, INC.
FACT, ARC, LYNX AND GUARDIAN BALLOON CORONARY DILATATION CATHETERS1998-02-20

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