Prostate Immobilizer Rectal Balloon
Regulation 892.5720
0510(k)s in 12 months (5 all time)
0recalls in 12 months (2 all time)
0recalls that name a 510(k)
Top companies in PCT
| Company | 510(k)s | Recalls |
|---|---|---|
| Angiodynamics, Inc. | 0 | 2 |
| Dxtx Medical, Inc. | 1 | 0 |
| Edge Medical, LLC | 1 | 0 |
| Myriad Medical, LLC | 1 | 0 |
| Qlrad International , Ltd. | 1 | 0 |
| Radiadyne | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 18, 2025 | Angiodynamics, Inc. IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60; Open, Classified |
PCT | None listed |
| Jul 3, 2024 | Angiodynamics, Inc. IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100 Open, Classified |
PCT | None listed |
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