Product code PHN ยท Class U
Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
2510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PHN
| Company | 510(k)s | Recalls |
|---|---|---|
| 3-D Matrix, Inc. | 2 | 0 |
| 3-D Matrix Europe SAS | 2 | 0 |
| Access Pharmaceuticals, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 3, 2026 | K261504 | PuraStat-RM 3-D Matrix, Inc. | PHN |
| Jan 7, 2026 | K253923 | PuraStat 3-D Matrix Europe SAS, FR | PHN |
| Jan 15, 2025 | K242634 | PuraStat 3-D Matrix Europe SAS, FR | PHN |
| Apr 1, 2022 | K213552 | PuraStat-RM 3-D Matrix, Inc. | PHN |
| Jul 16, 2014 | K140558 | PROCTIGARD Access Pharmaceuticals, Inc. | PHN |
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