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THERAGENICS CORP.

US

Last updated September 17, 2026

Information

Country
US
Address
5203 BRISTOL INDUSTRIAL WAY, BUFORD, GA, 30518
Website
—
LinkedIn
—
Facebook
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Email
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Phone
—
PRRC Contact
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EUDAMED SRN
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FDA FEI Number
1037598
DUNS Number
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Catalogue (187)

Page 4 of 4
DeviceModel / ReferenceRegistriesClassStatus
TheraSeed XX200
FDA UDI
Class IIActive
I-Seed Agx100 XX5057iN
FDA UDI
Class IIActive
Theragenics CPPS-MN-1820-1
FDA UDI
Class IActive
I-Seed Agx100 XX620xi
FDA UDI
Class IIActive
TheraSeed XXmmN
FDA UDI
Class IIActive
AnchorSeed with I-Seed XX77215iF
FDA UDI
Class IIActive
I-Seed Agx100 XX52xi
FDA UDI
Class IIActive
TheraSeed XX1520N
FDA UDI
Class IIActive
TheraSeed XX1220
FDA UDI
Class IIActive
TheraSeed XX1525
FDA UDI
Class IIActive
AnchorSeed with TheraSeed® XX77215N
FDA UDI
Class IIActive
AnchorSeed with I-Seed XX77215iN
FDA UDI
Class IIActive
Theragenics CPPS-BT-1820X-NS
FDA UDI
Class IActive
Theragenics CPPS-MN-1820-5
FDA UDI
Class IActive
Theragenics PSS-910-55-150NS
FDA UDI
Class IIActive
AnchorLoad with I-Seed XX782xi
FDA UDI
Class IIActive
VariStrand with OncoSeed ON772xi
FDA UDI
Class IIActive
TheraSleeve® with I-Seed XX992xi
FDA UDI
Class IIActive
Theragenics CPPS-MN-1821-1
FDA UDI
Class IActive
TheraMark™ TG77412i
FDA UDI
Class IIActive
TheraSeed XXmmC
FDA UDI
Class IIActive
I-Seed Agx100 XX65xi
FDA UDI
Class IIActive
TheraSleeve® with I-Seed XX92xi
FDA UDI
Class IIActive
AnchorSeed with I-Seed XX77315iF
FDA UDI
Class IIActive
TheraSeed XX20x
FDA UDI
Class IIActive
Theragenics CPPS-BT-1820
FDA UDI
Class IActive
TheraSeed XX607
FDA UDI
Class IIActive
VariStrand with TheraSeed® XX772x
FDA UDI
Class IIActive
TheraSleeve® with TheraSeed® XX92x
FDA UDI
Class IIActive
TheraSeed XX400
FDA UDI
Class IIActive
Theragenics CPPS-1720X-5
FDA UDI
Class IActive
I-Seed Agx100 XX500i
FDA UDI
Class IIActive
Modified Palladium Seed Model 100 K874787
FDA 510(k)
Class IIActive
Theraseed(r) Palladium-103 Implant; Model 200 K010283
FDA 510(k)
Class IIActive
Poiint Of Care Stranding System, Mode 1004-00 K072296
FDA 510(k)
Class IIActive
Theraload Custom Loaded Needles, Models 200 And 125.s06 K043596
FDA 510(k)
Class IIActive
I-Seed K103319
FDA 510(k)
Class IIActive

Related Companies

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Importers

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Notified Bodies

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Authorities

Not available yet.

FDA Recalls (3)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Oct 9, 2018Z-0643-2019—terminated

Some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed

Dec 8, 2008Z-1020-2009—terminated

Some pouches were found to have weak seals potentially compromising sterility.

May 16, 2005Z-0974-05—terminated

The spacers loaded in the seeding cartridges were expired and/or the extra loose spacers were labeled with an incorrect expiration date.