Company ยท US
Isoray Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2020. 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
| Code | Device | Records |
|---|---|---|
| KXK | Source, Brachytherapy, Radionuclide | 5 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 31, 2020 | K202267 | Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles Isoray Medical, Inc. | KXK |
| Jul 6, 2018 | K180515 | GammaTile Isoray Medical, Inc. | KXK |
| Aug 5, 2011 | K111931 | GLIASITE RTS Isoray Medical, Inc. | KXK |
| Aug 28, 2009 | K092458 | PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-2 Isoray Medical, Inc. | KXK |
| Aug 7, 2009 | K092136 | PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5 Isoray Medical, Inc. | KXK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||