Theragenics Corp

FDA Filings

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

FDA Registration(s)

• Registration Number: 3011623145
• FEI Number: 3011623145
• Name: David Derrick
• Owner & Operator: THERAGENICS CORP.
• Contact Address: 5203 BRISTOL INDUSTRIAL WAY --; Buford GA 30518 US
• US Agent:
  • David Derrick
  • Galt Medical Corp
  • 214 7781306
  • 972 2714706
  • dderrick@galtmedical.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2200 Merritt Dr ; Garland, TX 75041 US
• Establishment Type:
  • Manufacture Medical Device
  • Export Device to the United States But Perform No Other Operation on Device

• Registration Number: 3012164473
• FEI Number: 3012164473
• Name: CP MEDICAL, INC.
• Owner & Operator: THERAGENICS CORP.
• Contact Address: 5203 BRISTOL INDUSTRIAL WAY --; Buford GA 30518 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1775 Corporate Dr Ste 150 ; Norcross, GA 30093 US
• Establishment Type:
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

• Registration Number: 1649395
• FEI Number: 3000718472
• Name: GALT MEDICAL CORP.
• Owner & Operator: THERAGENICS CORP.
• Contact Address: 5203 BRISTOL INDUSTRIAL WAY --; Buford GA 30518 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2220 Merritt Dr ; GARLAND, TX 75041 US
• Establishment Type:
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198
  • Repack or Relabel Medical Device

• Registration Number: 3006283319
• FEI Number: 3006283319
• Name: NeedleTech Products, Inc.
• Owner & Operator: THERAGENICS CORP.
• Contact Address: 5203 BRISTOL INDUSTRIAL WAY --; Buford GA 30518 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 452 John L Dietsch Blvd ; N Attleboro, MA 02763 US
• Establishment Type:
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Device in the United States for Export Only

• Registration Number: 1037598
• FEI Number: 1037598
• Name: THERAGENICS CORP.
• Owner & Operator: THERAGENICS CORP.
• Contact Address: 5203 BRISTOL INDUSTRIAL WAY --; Buford GA 30518 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 5203 BRISTOL INDUSTRIAL WAY ; BUFORD, GA 30518 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 00813787022338 THERAGENICS CORPORATION	TheraMark™	2022-06-02
GUDID 00813787022321 THERAGENICS CORPORATION	TheraMark™	2022-06-02
GUDID 00813787022314 THERAGENICS CORPORATION	TheraMark™	2022-06-02
GUDID 00813787022307 THERAGENICS CORPORATION	TheraMark™	2022-06-02
GUDID 00813787022291 THERAGENICS CORPORATION	TheraMark™	2022-06-02
GUDID 00813787022284 THERAGENICS CORPORATION	TheraMark™	2022-06-02
GUDID 00813787022277 THERAGENICS CORPORATION	TheraMark™	2022-06-02
GUDID 00813787022260 THERAGENICS CORPORATION	TheraMark™	2022-06-02
GUDID 00813787022253 THERAGENICS CORPORATION	TheraMark™	2022-06-02
GUDID 00813787021751 THERAGENICS CORPORATION	Theragenics	2022-05-04
GUDID 00813787021744 THERAGENICS CORPORATION	Theragenics	2022-05-04
GUDID 00813787021737 THERAGENICS CORPORATION	Theragenics	2022-05-04
GUDID 00813787021911 THERAGENICS CORPORATION	Theragenics	2021-05-06
GUDID 00813787022048 THERAGENICS CORPORATION	Theragenics	2021-04-20
GUDID 00813787022031 THERAGENICS CORPORATION	Theragenics	2021-04-20
GUDID 00813787021980 THERAGENICS CORPORATION	Theragenics	2020-09-30
GUDID 00813787021867 THERAGENICS CORPORATION	Theragenics	2020-07-23
GUDID 00813787021850 THERAGENICS CORPORATION	Theragenics	2020-07-23
GUDID 00813787021843 THERAGENICS CORPORATION	Theragenics	2020-07-23
GUDID 00813787021829 THERAGENICS CORPORATION	Theragenics	2020-07-23
GUDID 00813787021812 THERAGENICS CORPORATION	Theragenics	2020-07-23
GUDID 00813787021805 THERAGENICS CORPORATION	Theragenics	2020-07-23
GUDID 00813787021799 THERAGENICS CORPORATION	Theragenics	2020-07-23
GUDID 00813787021836 THERAGENICS CORPORATION	Theragenics	2020-07-16
PMN K192195 | DYB GALT MEDICAL CORP. [THERAGENICS CORP.]	Dilator	2020-03-09
PMN K192195 | DYB David Derrick [THERAGENICS CORP.]	Dilator	2020-03-09
PMN K192195 | DRE GALT MEDICAL CORP. [THERAGENICS CORP.]	Dilator	2020-03-09
PMN K192195 | DRE David Derrick [THERAGENICS CORP.]	Dilator	2020-03-09
PMN K182660 | DTL GALT MEDICAL CORP. [THERAGENICS CORP.]	GaltTWS	2019-06-06
PMN K182660 | DRB GALT MEDICAL CORP. [THERAGENICS CORP.]	GaltTWS	2019-06-06
PMN K182660 | DQX GALT MEDICAL CORP. [THERAGENICS CORP.]	GaltTWS	2019-06-06
PMN K173922 | NBY CP MEDICAL, INC. [THERAGENICS CORP.]	C-PTFE Surgical Suture	2018-12-14
GUDID 00813787020792 THERAGENICS CORPORATION	TheraStrand® with TheraSeed®	2018-07-06
GUDID 00813787020785 THERAGENICS CORPORATION	TheraStrand® with TheraSeed®	2018-07-06
GUDID 00813787020778 THERAGENICS CORPORATION	TheraStrand® with TheraSeed®	2018-07-06
GUDID 00813787020761 THERAGENICS CORPORATION	TheraSeed	2018-07-06
GUDID 00813787020754 THERAGENICS CORPORATION	TheraSeed	2018-07-06
GUDID 00813787020747 THERAGENICS CORPORATION	TheraSeed	2018-07-06
GUDID 00813787020730 THERAGENICS CORPORATION	TheraSeed	2018-07-06
GUDID 00813787020723 THERAGENICS CORPORATION	TheraSeed	2018-07-06
GUDID 00813787020716 THERAGENICS CORPORATION	TheraSeed	2018-07-06
GUDID 00813787020709 THERAGENICS CORPORATION	TheraSeed	2018-07-06
GUDID 00813787020693 THERAGENICS CORPORATION	TheraSeed	2018-07-06
GUDID 00813787020686 THERAGENICS CORPORATION	TheraSeed	2018-07-06
GUDID 00813787020679 THERAGENICS CORPORATION	TheraSeed	2018-07-06
GUDID 00813787020662 THERAGENICS CORPORATION	TheraSeed	2018-07-06
GUDID 00813787020655 THERAGENICS CORPORATION	TheraSeed	2018-07-06
GUDID 00813787020648 THERAGENICS CORPORATION	TheraSeed	2018-07-06
GUDID 00813787020631 THERAGENICS CORPORATION	TheraSeed	2018-07-06
GUDID 00813787020624 THERAGENICS CORPORATION	TheraSeed	2018-07-06
GUDID 00813787020617 THERAGENICS CORPORATION	TheraSeed	2018-07-06
GUDID 00813787020600 THERAGENICS CORPORATION	TheraSeed	2018-07-06
GUDID 00813787020594 THERAGENICS CORPORATION	TheraSeed	2018-07-06
GUDID 00813787020587 THERAGENICS CORPORATION	TheraSeed	2018-07-06
GUDID 00813787020570 THERAGENICS CORPORATION	TheraSeed	2018-07-06
GUDID 00813787020563 THERAGENICS CORPORATION	TheraSeed	2018-07-06
GUDID 00813787020556 THERAGENICS CORPORATION	TheraSeed	2018-07-06
GUDID 00813787020549 THERAGENICS CORPORATION	TheraSeed	2018-07-06
GUDID 00813787020532 THERAGENICS CORPORATION	TheraSeed	2018-07-06
GUDID 00813787020525 THERAGENICS CORPORATION	TheraSeed	2018-07-06
GUDID 00813787020518 THERAGENICS CORPORATION	TheraSeed	2018-07-06
GUDID 00813787020495 THERAGENICS CORPORATION	TheraSleeve® with I-Seed	2018-07-06
GUDID 00813787020471 THERAGENICS CORPORATION	TheraLoad® with I-Seed	2018-07-06
GUDID 00813787020464 THERAGENICS CORPORATION	TheraStrand® with I-Seed	2018-07-06
GUDID 00813787020457 THERAGENICS CORPORATION	TheraStrand® with I-Seed	2018-07-06
GUDID 00813787020440 THERAGENICS CORPORATION	TheraStrand® with I-Seed	2018-07-06
GUDID 00813787020433 THERAGENICS CORPORATION	TheraSleeve® with I-Seed	2018-07-06
GUDID 00813787020419 THERAGENICS CORPORATION	TheraSleeve® with I-Seed	2018-07-06
GUDID 00813787020396 THERAGENICS CORPORATION	TheraLoad® with I-Seed	2018-07-06
GUDID 00813787020389 THERAGENICS CORPORATION	TheraStrand® with I-Seed	2018-07-06
GUDID 00813787020372 THERAGENICS CORPORATION	TheraStrand® with I-Seed	2018-07-06
GUDID 00813787020365 THERAGENICS CORPORATION	TheraStrand® with I-Seed	2018-07-06
GUDID 00813787020358 THERAGENICS CORPORATION	TheraStrand® with I-Seed	2018-07-06
GUDID 00813787020341 THERAGENICS CORPORATION	I-Seed Agx100	2018-07-06
GUDID 00813787020334 THERAGENICS CORPORATION	I-Seed Agx100	2018-07-06
GUDID 00813787020327 THERAGENICS CORPORATION	TheraStrand® with I-Seed	2018-07-06
GUDID 00813787020310 THERAGENICS CORPORATION	TheraStrand® with I-Seed	2018-07-06
GUDID 00813787020303 THERAGENICS CORPORATION	TheraStrand® with I-Seed	2018-07-06
GUDID 00813787020297 THERAGENICS CORPORATION	I-Seed Agx100	2018-07-06
GUDID 00813787020280 THERAGENICS CORPORATION	I-Seed Agx100	2018-07-06
GUDID 00813787020273 THERAGENICS CORPORATION	I-Seed Agx100	2018-07-06
GUDID 00813787020266 THERAGENICS CORPORATION	I-Seed Agx100	2018-07-06
GUDID 00813787020259 THERAGENICS CORPORATION	I-Seed Agx100	2018-07-06
GUDID 00813787020242 THERAGENICS CORPORATION	I-Seed Agx100	2018-07-06
GUDID 00813787020235 THERAGENICS CORPORATION	I-Seed Agx100	2018-07-06
GUDID 00813787020228 THERAGENICS CORPORATION	I-Seed Agx100	2018-07-06
GUDID 00813787020211 THERAGENICS CORPORATION	I-Seed Agx100	2018-07-06
GUDID 00813787020204 THERAGENICS CORPORATION	I-Seed Agx100	2018-07-06
GUDID 00813787020198 THERAGENICS CORPORATION	I-Seed Agx100	2018-07-06
GUDID 00813787020181 THERAGENICS CORPORATION	I-Seed Agx100	2018-07-06
GUDID 00813787020174 THERAGENICS CORPORATION	I-Seed Agx100	2018-07-06
GUDID 00813787020167 THERAGENICS CORPORATION	I-Seed Agx100	2018-07-06
GUDID 00813787020150 THERAGENICS CORPORATION	I-Seed Agx100	2018-07-06
GUDID 00813787020143 THERAGENICS CORPORATION	I-Seed Agx100	2018-07-06
GUDID 00813787020136 THERAGENICS CORPORATION	I-Seed Agx100	2018-07-06
GUDID 00813787020129 THERAGENICS CORPORATION	I-Seed Agx100	2018-07-06
GUDID 00813787020112 THERAGENICS CORPORATION	I-Seed Agx100	2018-07-06
GUDID 00813787020105 THERAGENICS CORPORATION	I-Seed Agx100	2018-07-06
GUDID 00813787020099 THERAGENICS CORPORATION	I-Seed Agx100	2018-07-06
GUDID 00813787020082 THERAGENICS CORPORATION	I-Seed Agx100	2018-07-06
GUDID 00813787020075 THERAGENICS CORPORATION	I-Seed Agx100	2018-07-06
GUDID 00813787020068 THERAGENICS CORPORATION	I-Seed Agx100	2018-07-06
GUDID 00813787020051 THERAGENICS CORPORATION	I-Seed Agx100	2018-07-06
GUDID 00813787020044 THERAGENICS CORPORATION	I-Seed Agx100	2018-07-06
GUDID 00813787020037 THERAGENICS CORPORATION	I-Seed Agx100	2018-07-06
GUDID 00813787020020 THERAGENICS CORPORATION	I-Seed Agx100	2018-07-06
GUDID 00813787020013 THERAGENICS CORPORATION	TheraSeed	2018-07-06
GUDID 00813787020006 THERAGENICS CORPORATION	TheraSeed	2018-07-06
PMN K172487 | DRE GALT MEDICAL CORP. [THERAGENICS CORP.]	Coaxial	2017-11-01
PMN K172487 | DRE David Derrick [THERAGENICS CORP.]	Coaxial	2017-11-01
PMN K974118 | IWJ THERAGENICS CORP.	SeedLock	2016-03-03
PMN K974118 | IWJ THERAGENICS CORP.	Brachytherapy Needle, Sterile, Pre-waxed	2016-03-03
PMN K974118 | IWJ THERAGENICS CORP.	Brachytherapy Needle, Sterile , Non-waxed	2016-03-03
PMN K974118 | IWJ THERAGENICS CORP.	Brachytherapy Applicator Needle	2016-03-03
PMN K023179 | KXK THERAGENICS CORP.	VariStrand	2016-01-15
PMN K023179 | KXK THERAGENICS CORP.	AnchorLoad	2016-01-15
PMN K083274 | KXK THERAGENICS CORP.	AnchorSeed	2016-01-13
PMN K083274 | KXK THERAGENICS CORP.	AnchorMarker	2016-01-13
PMN K143252 | DQX NeedleTech Products, Inc. [THERAGENICS CORP.]	QuickTork Guidewire Torque Device (0.025"-0.040") (TOR-100-25)	2015-12-24
PMN K143252 | DQX NeedleTech Products, Inc. [THERAGENICS CORP.]	QuickTork Guidewire Torque Device (0.010"-0.020") (TOR-100-10)	2015-12-24
PMN K143252 | DQX GALT MEDICAL CORP. [THERAGENICS CORP.]	QuickTork Guidewire Torque Device (0.025"-0.040") (TOR-100-25)	2015-12-24
PMN K143252 | DQX GALT MEDICAL CORP. [THERAGENICS CORP.]	QuickTork Guidewire Torque Device (0.010"-0.020") (TOR-100-10)	2015-12-24
PMN K094028 | GAT CP MEDICAL, INC. [THERAGENICS CORP.]	CP-Fiber, PowerFiber (Polyethylene suture)	2014-08-05
MIJ CP MEDICAL, INC. [THERAGENICS CORP.]	RPLN (Repositional Breast Localization Needle)	2014-08-05
PMN K123430 | DYB GALT MEDICAL CORP. [THERAGENICS CORP.]	MicroSlide Tearaway Introducer	2013-04-17
PMN K123430 | DYB David Derrick [THERAGENICS CORP.]	MicroSlide Tearaway Introducer	2013-04-17
PMN K112398 | DYB GALT MEDICAL CORP. [THERAGENICS CORP.]	Valved Tearaway Introducer	2012-12-27
KGZ GALT MEDICAL CORP. [THERAGENICS CORP.]	Galt VTI	2012-12-27
KGZ GALT MEDICAL CORP. [THERAGENICS CORP.]	Centeze Drainage Catheter	2012-12-27
GCB GALT MEDICAL CORP. [THERAGENICS CORP.]	CATHETER NEEDLE	2012-12-27
PMN K011493 | KPT THERAGENICS CORP.	IsoStrand Set	2012-06-08
PMN K011493 | KPT THERAGENICS CORP.	IsoLoader	2012-06-08
PMN K011493 | KPT THERAGENICS CORP.	IsoCartridge	2012-06-08
PMN K103319 | KXK THERAGENICS CORP.	I-Seed Model AgX100	2011-11-22
PMN K031173 | GDF NeedleTech Products, Inc. [THERAGENICS CORP.]	Guide Wire Introducer Needle	2011-05-03
PMN K103319 THERAGENICS CORP.	I-SEED	2011-01-03
GAA NeedleTech Products, Inc. [THERAGENICS CORP.]	SCP(TM) Delivery Cannula 8GA x 3.5"	2008-12-24
GAA NeedleTech Products, Inc. [THERAGENICS CORP.]	19g X 2 3/4 Premium Percutaneous Needle	2008-12-24
GAA NeedleTech Products, Inc. [THERAGENICS CORP.]	19g X 2 3/4 Premium Percutaneous Needle featuring Echogenic Tip	2008-12-24
PMN K982559 | DQX GALT MEDICAL CORP. [THERAGENICS CORP.]	Galt Medical Guidewire	2007-11-20
PMN K071330 | DRE GALT MEDICAL CORP. [THERAGENICS CORP.]	GaltStick	2007-11-20
PMN K071330 | DRE David Derrick [THERAGENICS CORP.]	GaltStick	2007-11-20
PMN K043525 | DYB GALT MEDICAL CORP. [THERAGENICS CORP.]	Elite HV	2007-11-20
PMN K043525 | DYB David Derrick [THERAGENICS CORP.]	Elite HV	2007-11-20
PMN K021990 | DQX GALT MEDICAL CORP. [THERAGENICS CORP.]	Nitinol Guidewires (Mandrel)	2007-11-20
PMN K000737 | DRE GALT MEDICAL CORP. [THERAGENICS CORP.]	Coaxial	2007-11-20
PMN K000737 | DRE David Derrick [THERAGENICS CORP.]	Coaxial	2007-11-20
PMN K000313 | DYB GALT MEDICAL CORP. [THERAGENICS CORP.]	Micro-Access Tearaway	2007-11-20
PMN K000313 | DYB David Derrick [THERAGENICS CORP.]	Micro-Access Tearaway	2007-11-20
PMN K072229 | GAM CP MEDICAL, INC. [THERAGENICS CORP.]	MONOSWIFT	2007-11-06
PMN K041894 | GAT CP MEDICAL, INC. [THERAGENICS CORP.]	POWERFIBER	2007-11-06
PMN K041894 | GAT CP MEDICAL, INC. [THERAGENICS CORP.]	ORTHOFIBER	2007-11-06
PMN K041894 | GAT CP MEDICAL, INC. [THERAGENICS CORP.]	CP-FIBER	2007-11-06
PMN K034062 | KXK THERAGENICS CORP.	CARRIER SLEEVE	2007-11-06
PMN K030351 | GAQ CP MEDICAL, INC. [THERAGENICS CORP.]	SURGICAL STEEL	2007-11-06
PMN K024372 | MTJ CP MEDICAL, INC. [THERAGENICS CORP.]	BONE WAX	2007-11-06
PMN K023710 | GAM CP MEDICAL, INC. [THERAGENICS CORP.]	VISORB SWIFT	2007-11-06
PMN K023710 | GAM CP MEDICAL, INC. [THERAGENICS CORP.]	VISORB QUICK	2007-11-06
PMN K022075 | DSA CP MEDICAL, INC. [THERAGENICS CORP.]	DISPOSABLE TEMPORARY PACING CABLE	2007-11-06
PMN K021311 | KXK THERAGENICS CORP.	POLYDIOXANONE SYNTHETIC ABSORBABLE SEEDING SPACER	2007-11-06
PMN K013975 | KXK THERAGENICS CORP.	CP Sleeve	2007-11-06
PMN K013964 | KXK THERAGENICS CORP.	BIOSPACER	2007-11-06
PMN K013964 | KXK THERAGENICS CORP.	ACCUSPACE	2007-11-06
PMN K013274 | NEW CP MEDICAL, INC. [THERAGENICS CORP.]	MONO-DOX	2007-11-06
PMN K010621 | KXK THERAGENICS CORP.	ACCUSPACE	2007-11-06
PMN K002190 | GAM CP MEDICAL, INC. [THERAGENICS CORP.]	VISORB	2007-11-06
PMN K001299 | GAL CP MEDICAL, INC. [THERAGENICS CORP.]	PLAIN GUT	2007-11-06
PMN K001299 | GAL CP MEDICAL, INC. [THERAGENICS CORP.]	CHROMIC GUT	2007-11-06
PMN K001185 | GAW CP MEDICAL, INC. [THERAGENICS CORP.]	POLYPRO	2007-11-06
PMN K001185 | GAW CP MEDICAL, INC. [THERAGENICS CORP.]	GLOSTITCH	2007-11-06
PMN K001185 | GAW CP MEDICAL, INC. [THERAGENICS CORP.]	FLUOROFIL	2007-11-06
PMN K001184 | GAP CP MEDICAL, INC. [THERAGENICS CORP.]	SILK	2007-11-06
PMN K001173 | GAR CP MEDICAL, INC. [THERAGENICS CORP.]	MONOMID	2007-11-06
PMN K001172 | GAT CP MEDICAL, INC. [THERAGENICS CORP.]	POLYBOND	2007-11-06
PMN K072296 | KXK THERAGENICS CORP.	In-STANT Stranding System	2007-11-05
PMN K071550 | KXK THERAGENICS CORP.	PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS	2007-11-05
PMN K043596 | KXK THERAGENICS CORP.	TheraStrand	2007-11-05
PMN K043596 | KXK THERAGENICS CORP.	TheraSleeve	2007-11-05
PMN K043596 | KXK THERAGENICS CORP.	TheraLoad	2007-11-05
PMN K040339 | KXK THERAGENICS CORP.	TheraStrand	2007-11-05
PMN K021343 | KXK THERAGENICS CORP.	I-Seed	2007-11-05
PMN K010283 | KXK THERAGENICS CORP.	TheraSeed	2007-11-05
PMN K072296 THERAGENICS CORP.	POIINT OF CARE STRANDING SYSTEM, MODE 1004-00	2007-09-26
DWS GALT MEDICAL CORP. [THERAGENICS CORP.]	GUIDEWIRE INTRODUCER NEEDLE	2005-12-30
PMN K043596 THERAGENICS CORP.	THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06	2005-01-26
KYZ GALT MEDICAL CORP. [THERAGENICS CORP.]	Syringe	2004-05-12
GES GALT MEDICAL CORP. [THERAGENICS CORP.]	Blade	2004-05-12
GAG CP MEDICAL, INC. [THERAGENICS CORP.]	XACT SURGICAL STAPLER	2003-09-11
EXM CP MEDICAL, INC. [THERAGENICS CORP.]	CP COTTON UMBILICAL TAPE	2003-04-28
PMN K010283 THERAGENICS CORP.	THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200	2001-04-26
IWJ CP MEDICAL, INC. [THERAGENICS CORP.]	CP GRID	1998-12-29
PMN K874787 THERAGENICS CORP.	MODIFIED PALLADIUM SEED MODEL 100	1987-12-22

Related Finance Registrations

NCAGE Code	07RV9	THERAGENICS CORPORATION
CAGE Code	07RV9	THERAGENICS CORPORATION
S.A.M. Registration	07RV9 [114379522]	THERAGENICS CORPORATION
SEC	0000795551	THERAGENICS CORP of DELAWARE