3-D Matrix, Inc.

FDA Regulatory Profile

3-D Matrix, Inc. appears in FDA public data with 1 recall, 7 510(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 February 28, 2023.

Summary

Total Recalls
1
510(k) Clearances
7
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0744-2022Class IIPuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006December 2, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K222481PuraStatFebruary 28, 2023
K213552PuraStat-RMApril 1, 2022
K210211PuraStat-OMOctober 8, 2021
K210098PuraStat-GIJune 25, 2021
K193085PuraDERM GelMay 11, 2020
K183015PuraSinusApril 12, 2019
K143058PuraDerm GelFebruary 13, 2015