Company ยท US
Radiadyne
FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2017. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 1, 2017 | K162954 | OARtrac System with Patient Specific Reusable Universal PSD Sensors Radiadyne, LLC | NZT |
| Jun 16, 2015 | K150719 | OARtrac System with Skin Sensors Radiadyne, LLC | NZT |
| Jul 22, 2014 | K141154 | OARTRAC SYSTEM Radiadyne | NZT |
| Jan 28, 2014 | DEN130036 | PROSTATE IMMOBILIZER RECTAL BALLOON Radiadyne | PCT |
| Dec 7, 2009 | K092534 | ALATUS VAGINAL BALLOON PACKING SYSTEM Radiadyne | JAQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||