Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Radiadyne with 5 510(k) clearances. The most recent is a 510(k) clearance dated Jun 1, 2017: OARtrac System with Patient Specific Reusable Universal PSD Sensors.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jun 1, 2017 | OARtrac System with Patient Specific Reusable Universal PSD SensorsK162954 · NZT | 510(k) clearances |
| Jun 16, 2015 | OARtrac System with Skin SensorsK150719 · NZT | 510(k) clearances |
| Jul 22, 2014 | OARTRAC SYSTEMK141154 · NZT | 510(k) clearances |
| Jan 28, 2014 | PROSTATE IMMOBILIZER RECTAL BALLOONDEN130036 · PCT | 510(k) clearances |
| May 3, 2012 | RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICEK120344 · JAQ | 510(k) clearances |
| Dec 7, 2009 | ALATUS VAGINAL BALLOON PACKING SYSTEMK092534 · JAQ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
