ClearanceBrief
Company ยท US

3-D Matrix, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2015 to 2026. Name variants (Inc, Corp, punctuation) are merged.

9510(k) clearances (2 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)

Product codes

CodeDeviceRecords
QAUHemostatic Device For Endoscopic Gastrointestinal Use3
FRODressing, Wound, Drug2
NHBPolymer, Ear, Nose And Throat, Synthetic, Absorbable2
PHNProtective Coating, Mucoadhesive Application, For The Rectal Mucosa2
OLROral Wound Dressing1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Aug 3, 2026K261504PuraStat-RM
3-D Matrix, Inc.
PHN
Aug 3, 2026K261503PuraStat GI
3-D Matrix, Inc.
QAU
Feb 28, 2023K222481PuraStat
3-D Matrix, Inc.
QAU
Apr 1, 2022K213552PuraStat-RM
3-D Matrix, Inc.
PHN
Oct 8, 2021K210211PuraStat-OM
3-D Matrix, Inc.
OLR
Jun 25, 2021K210098PuraStat-GI
3-D Matrix, Inc.
QAU
May 11, 2020K193085PuraDERM Gel
3-D Matrix, Inc.
FRO
Apr 12, 2019K183015PuraSinus
3-D Matrix, Inc.
NHB
Feb 13, 2015K143058PuraDerm Gel
3-D Matrix, Inc.
FRO

Latest recalls

DateFirm and productCodeLinked 510(k)
Dec 2, 20193-D Matrix, Inc.
PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006
Terminated		 NHBK183015
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