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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 10, 2023 | K223249 | Pro-Tx Endorectal Balloon (PROT-25) Dxtx Medical, Inc. | PCT |
| Nov 13, 2018 | K180478 | RectalPro 75 Endorectal Balloon Qlrad International , Ltd., NL | PCT |
| Mar 31, 2015 | K150234 | Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301 Myriad Medical, LLC | PCT |
| Nov 18, 2014 | K141958 | ERB ENDORECTAL BALLOON Edge Medical, LLC | PCT |
| Jan 28, 2014 | DEN130036 | PROSTATE IMMOBILIZER RECTAL BALLOON Radiadyne | PCT |
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