3-D Matrix, Inc.
FDA Regulatory Profile
3-D Matrix, Inc. appears in FDA public data with 1 recall, 9 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0744-2022, Class II) was initiated on December 2, 2019. Its most recent 510(k) clearance was granted on August 3, 2026.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 9
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0744-2022 | Class II | PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006 | December 2, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K261503 | PuraStat GI | August 3, 2026 |
| K261504 | PuraStat-RM | August 3, 2026 |
| K222481 | PuraStat | February 28, 2023 |
| K213552 | PuraStat-RM | April 1, 2022 |
| K210211 | PuraStat-OM | October 8, 2021 |
| K210098 | PuraStat-GI | June 25, 2021 |
| K193085 | PuraDERM Gel | May 11, 2020 |
| K183015 | PuraSinus | April 12, 2019 |
| K143058 | PuraDerm Gel | February 13, 2015 |