Theragenics Corp. FDA Record
Theragenics Corp. has 1 FDA recall, 3 inspections, 5 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Theragenics Corp." is on file.
- Latest recall
- Z-0643-2019 · Class II · Oct 9, 2018
- Latest inspection
- Apr 14, 2017 · VAI
- Latest 510(k)
- Jan 3, 2011
Reviewing Theragenics Corp. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Or check Theragenics Corp. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 1 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 5 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 3 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 1 | 0 |
| 2017 | 1 | 0 | 0 | 0 | 0 |
Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0643-2019 | Class II | Theragenics Applicator Needle (18g x 20cm) The device is comprised four basic elements; a wire… | Oct 9, 2018 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 14, 2017 | Buford, GA | Devices | Voluntary Action Indicated (VAI) | 1037598 |
| Sep 25, 2013 | Buford, GA | Devices | No Action Indicated (NAI) | 1037598 |
| Mar 30, 2011 | Buford, GA | Devices | No Action Indicated (NAI) | 1037598 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 1037598 | Buford, GA | 3 | Apr 14, 2017 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K103319 | I-SEED | Jan 3, 2011 |
| K072296 | POIINT OF CARE STRANDING SYSTEM, MODE 1004-00 | Sep 26, 2007 |
| K043596 | THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06 | Jan 26, 2005 |
| K010283 | THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200 | Apr 26, 2001 |
| K874787 | MODIFIED PALLADIUM SEED MODEL 100 | Dec 22, 1987 |
Theragenics Corp. and the FDA: common questions
Has Theragenics Corp. received an FDA warning letter?
No FDA warning letter addressed to the name "Theragenics Corp." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Theragenics Corp. received an FDA Form 483?
FDA has not published a Form 483 for "Theragenics Corp." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Theragenics Corp.?
The most recent FDA inspection on file ended Apr 14, 2017 at Buford, GA and was classified VAI. FDA has 3 inspections of Theragenics Corp. on file.
Has Theragenics Corp. had an FDA recall?
Yes. Theragenics Corp. has 1 FDA recall on record. The most recent started Oct 9, 2018.
Need more than this page shows? Ask about Theragenics Corp. in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.