Galt Medical Corp

FDA Filings

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

Galt Medical Corp holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number1649395
FEI Number3000718472
NameGALT MEDICAL CORP.
Owner & OperatorTHERAGENICS CORP.
Contact Address5203 BRISTOL INDUSTRIAL WAY --
Buford GA 30518 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2220 Merritt Dr
GARLAND, TX 75041 US
Establishment Type
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198
  • Repack or Relabel Medical Device



FDA Filings

Device
Company
DeviceDate
GALT MEDICAL CORP.
Elite Transitionless Micro-Introducer Kit KIT-099-192022-08-23
GALT MEDICAL CORP.
Elite Transitionless Micro-Introducer Kit KIT-099-182022-08-23
GALT MEDICAL CORP.
Elite Transitionless Micro-Introducer Kit KIT-099-172022-08-23
GALT MEDICAL CORP.
Elite Transitionless Micro-Introducer Kit KIT-099-142022-08-23
GALT MEDICAL CORP.
Elite Transitionless Micro-Introducer Kit KIT-099-132022-08-23
GALT MEDICAL CORP.
Elite Transitionless Micro-Introducer Kit KIT-099-062022-08-23
GALT MEDICAL CORP.
Elite Transitionless Micro-Introducer Kit KIT-099-052022-08-23
GALT MEDICAL CORP.
Elite Transitionless Micro-Introducer Kit KIT-099-042022-08-23
GALT MEDICAL CORP.
Elite Transitionless Micro-Introducer Kit KIT-099-032022-08-23
GALT MEDICAL CORP.
Elite Transitionless Micro-Introducer Kit KIT-099-022022-08-23
GALT MEDICAL CORP.
Elite Transitionless Micro-Introducer Kit KIT-099-012022-08-23
GALT MEDICAL CORP.
Elite Transitionless Micro-Introducer Kit KIT-098-202022-08-23
GALT MEDICAL CORP.
Elite Transitionless Micro-Introducer Kit KIT-098-192022-08-23
GALT MEDICAL CORP.
Elite Transitionless Micro-Introducer Kit KIT-098-182022-08-23
GALT MEDICAL CORP.
Elite Transitionless Micro-Introducer Kit KIT-098-172022-08-23
GALT MEDICAL CORP.
Elite Transitionless Micro-Introducer Kit KIT-098-132022-08-23
GALT MEDICAL CORP.
Elite Transitionless Micro-Introducer Kit KIT-098-082022-08-23
GALT MEDICAL CORP.
Elite Transitionless Micro-Introducer Kit KIT-098-072022-08-23
GALT MEDICAL CORP.
Elite Transitionless Micro-Introducer Kit KIT-098-062022-08-23
GALT MEDICAL CORP.
Elite Transitionless Micro-Introducer Kit KIT-098-052022-08-23
GALT MEDICAL CORP.
Elite Transitionless Micro-Introducer Kit KIT-098-042022-08-23
GALT MEDICAL CORP.
Elite Transitionless Micro-Introducer Kit KIT-098-032022-08-23
GALT MEDICAL CORP.
Elite Transitionless Micro-Introducer Kit KIT-098-022022-08-23
GALT MEDICAL CORP.
Elite Transitionless Micro-Introducer Kit KIT-098-012022-08-23
GALT MEDICAL CORP.
Stiffen Micro-Introducer Kit KIT-076-022022-04-27
GALT MEDICAL CORP.
Tearaway Introducer Set INT-128-172022-04-27
GALT MEDICAL CORP.
Tearaway Introducer Set INT-128-162022-04-27
GALT MEDICAL CORP.
Tearaway Introducer Set INT-128-152022-04-27
GALT MEDICAL CORP.
Tearaway Introducer Set INT-128-042022-04-27
GALT MEDICAL CORP.
Tearaway Introducer Set INT-128-032022-04-27
GALT MEDICAL CORP.
Tearaway Introducer Set INT-128-022022-04-27
GALT MEDICAL CORP.
Tearaway Introducer Set INT-128-012022-04-27
GALT MEDICAL CORP.
Guidewire SGW-073-022021-11-08
GALT MEDICAL CORP.
Guidewire SGW-072-012021-11-08
GALT MEDICAL CORP.
Guidewire SGW-072-002021-11-08
GALT MEDICAL CORP.
Guidewire SGW-070-722021-11-08
GALT MEDICAL CORP.
Guidewire SGW-071-002021-11-08
GALT MEDICAL CORP.
Guidewire SGW-056-732021-11-08
GALT MEDICAL CORP.
Guidewire SGW-056-692021-11-08
GALT MEDICAL CORP.
Tearaway Sheath Introducer INT-117-162021-11-08
GALT MEDICAL CORP.
Guidewire SGW-056-042021-11-08
GALT MEDICAL CORP.
Guidewire SGW-015-082021-11-08
GALT MEDICAL CORP.
Micro-Introducer Kit KIT-096-002021-11-08
GALT MEDICAL CORP.
4F x 60cm Micro-Introducer Kit INT04602021-11-08
GALT MEDICAL CORP.
Tearaway Introducer Set INT-116-162021-11-08
GALT MEDICAL CORP.
Elite HV® F Introducer Kit CLI-115-162021-06-14
GALT MEDICAL CORP.
Elite HV® F Introducer Kit CLI-115-152021-06-14
GALT MEDICAL CORP.
Elite HV® F Introducer Kit CLI-115-142021-06-14
GALT MEDICAL CORP.
Elite HV® F Introducer Kit CLI-115-072021-06-14
GALT MEDICAL CORP.
Elite HV® F Introducer Kit CLI-114-162021-06-14
GALT MEDICAL CORP.
Elite HV® F Introducer Kit CLI-114-152021-06-14
GALT MEDICAL CORP.
Elite HV® F Introducer Kit CLI-114-072021-06-14
GALT MEDICAL CORP.
Elite HV® F Introducer Kit CLI-113-162021-06-14
GALT MEDICAL CORP.
Elite HV® F Introducer Kit CLI-113-152021-06-14
GALT MEDICAL CORP.
Elite HV® F Introducer Kit CLI-113-072021-06-14
GALT MEDICAL CORP.
Elite HV Introducer Set CLI-102-412021-06-14
GALT MEDICAL CORP.
Dilator DIL-501-212021-06-14
GALT MEDICAL CORP.
Dilator DIL-501-192021-06-14
GALT MEDICAL CORP.
Elite HV® R Hydrophilic Introducer Kit CLI-231-552020-12-21
GALT MEDICAL CORP.
Elite HV® R Hydrophilic Introducer Kit CLI-231-452020-12-21
GALT MEDICAL CORP.
Elite HV® R Hydrophilic Introducer Kit CLI-231-072020-12-21
GALT MEDICAL CORP.
Elite HV® R Hydrophilic Introducer Kit CLI-231-062020-12-21
GALT MEDICAL CORP.
Elite HV® R Hydrophilic Introducer Kit CLI-230-552020-12-21
GALT MEDICAL CORP.
Elite HV® R Hydrophilic Introducer Kit CLI-230-452020-12-21
GALT MEDICAL CORP.
Elite HV® R Hydrophilic Introducer Kit CLI-230-072020-12-21
GALT MEDICAL CORP.
Elite HV® R Hydrophilic Introducer Kit CLI-230-062020-12-21
GALT MEDICAL CORP.
Elite HV® R Hydrophilic Introducer Kit CLI-229-552020-12-21
GALT MEDICAL CORP.
Elite HV® R Hydrophilic Introducer Kit CLI-229-452020-12-21
GALT MEDICAL CORP.
Elite HV® R Hydrophilic Introducer Kit CLI-229-072020-12-21
GALT MEDICAL CORP.
Elite HV® R Hydrophilic Introducer Kit CLI-229-062020-12-21
GALT MEDICAL CORP.
Elite HV® R Hydrophilic Introducer Kit CLI-228-552020-12-21
GALT MEDICAL CORP.
Elite HV® R Hydrophilic Introducer Kit CLI-228-452020-12-21
GALT MEDICAL CORP.
Elite HV® R Hydrophilic Introducer Kit CLI-228-072020-12-21
GALT MEDICAL CORP.
Elite HV® R Hydrophilic Introducer Kit CLI-228-062020-12-21
GALT MEDICAL CORP.
Micro-Access Tearaway Introducer Kit 3675742020-12-15
GALT MEDICAL CORP.
Micro-Access Tearaway Introducer Kit 3675732020-12-15
GALT MEDICAL CORP.
Micro-Access Tearaway Introducer Kit 3675722020-12-15
GALT MEDICAL CORP.
Micro-Access Tearaway Introducer Kit 3675712020-12-15
GALT MEDICAL CORP.
Micro-Access Tearaway Introducer Kit 4357862020-12-15
GALT MEDICAL CORP.
Micro-Access Tearaway Introducer Kit 3675702020-12-15
GALT MEDICAL CORP.
Micro-Access Tearaway Introducer Kit 3675692020-12-15
GALT MEDICAL CORP.
Micro-Access Tearaway Introducer Kit 3675682020-12-15
GALT MEDICAL CORP.
Micro-Access Tearaway Introducer Kit 3675672020-12-15
GALT MEDICAL CORP.
Hydrophilic M-Drain® Introducer Kit DS20104002020-12-15
GALT MEDICAL CORP.
Hydrophilic M-Drain® Introducer Kit DS20103002020-12-15
GALT MEDICAL CORP.
Hydrophilic M-Drain® Introducer Kit DS20102002020-12-15
GALT MEDICAL CORP.
Hydrophilic M-Drain® Introducer Kit DS20101002020-12-15
GALT MEDICAL CORP.
M-Drain® Centesis Catheter D401050202020-12-15
GALT MEDICAL CORP.
M-Drain® Centesis Catheter D401050152020-12-15
GALT MEDICAL CORP.
M-Drain® Centesis Catheter D401050102020-12-15
GALT MEDICAL CORP.
M-Drain® Centesis Catheter D401050072020-12-15
GALT MEDICAL CORP.
M-Drain® Centesis Catheter D401040152020-12-15
GALT MEDICAL CORP.
M-Drain® Centesis Catheter D401040102020-12-15
GALT MEDICAL CORP.
M-Drain® Centesis Catheter D401040072020-12-15
GALT MEDICAL CORP.
Guidewire SGW-056-752020-12-15
GALT MEDICAL CORP.
Guidewire USEGS18-180S2020-12-15
GALT MEDICAL CORP.
Posi-Stick® Dilator DIL-0810122020-12-15
GALT MEDICAL CORP.
Elite HV Transitionless Hemostasis Valve Introducer Kit CLI-124-162020-12-14
GALT MEDICAL CORP.
Elite HV Transitionless Hemostasis Valve Introducer Kit CLI-124-152020-12-14
GALT MEDICAL CORP.
Elite HV Transitionless Hemostasis Valve Introducer Kit CLI-124-142020-12-14
GALT MEDICAL CORP. [THERAGENICS CORP.]
Dilator2020-03-09
GALT MEDICAL CORP. [THERAGENICS CORP.]
Dilator2020-03-09
Galt Medical Corp.
Sterile Dilator2019-09-26
GALT MEDICAL CORP. [THERAGENICS CORP.]
GaltTWS2019-06-06
GALT MEDICAL CORP. [THERAGENICS CORP.]
GaltTWS2019-06-06
GALT MEDICAL CORP. [THERAGENICS CORP.]
GaltTWS2019-06-06
Galt Medical Corp.
GaltTWS2019-05-30
Galt Medical Corp.
Elite HV Radial2017-12-21
GALT MEDICAL CORP. [THERAGENICS CORP.]
Coaxial2017-11-01
Galt Medical Corp.
Coaxial Dilator Set (Micro-Introducer)2017-10-16
GALT MEDICAL CORP.
Tearaway Introducer Sheath, MicroSlide Tearaway Introducer2016-07-05
GALT MEDICAL CORP. [THERAGENICS CORP.]
QuickTork Guidewire Torque Device (0.025"-0.040") (TOR-100-25)2015-12-24
GALT MEDICAL CORP. [THERAGENICS CORP.]
QuickTork Guidewire Torque Device (0.010"-0.020") (TOR-100-10)2015-12-24
GALT MEDICAL CORP.
Attachable Cath Lab Hemostasis Valve2015-12-02
GALT MEDICAL CORP.
GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER2014-08-21
GALT MEDICAL CORP. [THERAGENICS CORP.]
MicroSlide Tearaway Introducer2013-04-17
GALT MEDICAL CORP.
MICROSLIDER TEARAWAY INTRODUCER SET2013-04-12
GALT MEDICAL CORP. [THERAGENICS CORP.]
Valved Tearaway Introducer2012-12-27
GALT MEDICAL CORP. [THERAGENICS CORP.]
Galt VTI2012-12-27
GALT MEDICAL CORP. [THERAGENICS CORP.]
Centeze Drainage Catheter2012-12-27
GALT MEDICAL CORP. [THERAGENICS CORP.]
CATHETER NEEDLE2012-12-27
GALT MEDICAL CORP. [THERAGENICS CORP.]
Galt Medical Guidewire2007-11-20
GALT MEDICAL CORP. [THERAGENICS CORP.]
GaltStick2007-11-20
GALT MEDICAL CORP. [THERAGENICS CORP.]
Elite HV2007-11-20
GALT MEDICAL CORP. [THERAGENICS CORP.]
Nitinol Guidewires (Mandrel)2007-11-20
GALT MEDICAL CORP. [THERAGENICS CORP.]
Coaxial2007-11-20
GALT MEDICAL CORP. [THERAGENICS CORP.]
Micro-Access Tearaway2007-11-20
GALT MEDICAL CORP.
GALTSTICK INTRODUCER SYSTEM2007-10-31
GALT MEDICAL CORP. [THERAGENICS CORP.]
GUIDEWIRE INTRODUCER NEEDLE2005-12-30
GALT MEDICAL CORP.
CATHETER INTRODUCER2005-02-09
GALT MEDICAL CORP. [THERAGENICS CORP.]
Syringe2004-05-12
GALT MEDICAL CORP. [THERAGENICS CORP.]
Blade2004-05-12
GALT MEDICAL CORP.
EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE2003-12-05
GALT MEDICAL CORP.
GALT MEDICAL GUIDEWIRE2003-07-17
GALT MEDICAL CORP.
GALT MEDICAL GUIDEWIRE2002-07-18
GALT MEDICAL CORP.
GUIDEWIRE1999-02-01

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