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Prostate Immobilizer Rectal Balloon
FDA product code PCT · Class 2 · Radiology
17
Registered devices
1
Adverse events
2
Recalls
5
510(k) clearances
Devices with this code
IsoLoc — RADIADYNE, L.L.C.BIONIX RADIATION THERAPY — Bionix Radiation Therapy, LLCImmobiLoc — RADIADYNE, L.L.C.Prostate Caddy Rectal Balloon — Myriad Medical, LLCImmobiLoc — RADIADYNE, L.L.C.OARtrac — RADIADYNE, L.L.C.IsoLoc — RADIADYNE, L.L.C.BIONIX RADIATION THERAPY — Bionix Radiation Therapy, LLCImmobiLoc — RADIADYNE, L.L.C.QLRAD — QLRAD INTERNATIONAL LTDQLRAD — QLRAD INTERNATIONAL LTDIsoLoc — RADIADYNE, L.L.C.Prostate Caddy Rectal Balloon — Myriad Medical, LLCImmobiLoc — RADIADYNE, L.L.C.ImmobiLoc — RADIADYNE, L.L.C.Prostate Caddy Rectal Balloon — Myriad Medical, LLCQLRAD — QLRAD INTERNATIONAL LTD
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-02-04 | Angiodynamics, Inc. | Product is mislabeled with the incorrect fill volume. |
| 2024-05-21 | Angiodynamics, Inc. | A single batch of ISO-100 IsoLoc Gas-Release Endorectal Balloons is mislabeled. The affected ISO-100 balloon catheter has a nominal fill volume of 100cc/ml but |
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