Data / Medical devices / United States / 3-D Matrix, Inc.

3-D Matrix, Inc.: FDA-registered device maker in Newton, MA, United States, 7 510(k) clearances

Name: 3-D Matrix, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

3-D Matrix, Inc. is registered with the FDA (registration 3015528146) in Newton, MA, United States. It lists 6 device types. The FDA files 7 510(k) clearances under its listings, the newest dated August 3, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3015528146
Address: 1234 Chestnut St. Suite 205, Newton, MA, United States, 02464
Owner or operator: 3D-Matrix (10060325)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: April 25, 2019
Registered through: 2026
Brand names listed: PuraGel, PuraGel; PuraSinus - Oral Mucosa, PuraSinus, PuraStat, Syringe Adapter

Devices it lists

Device	Product code	Class	Role	Source
Connector, Catheter	GCD	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic	MGQ	U	Complaint file establishment, Manufacturer	accessdata.fda.gov
Hemostatic Device For Endoscopic Gastrointestinal Use	QAU	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Oral Wound Dressing	OLR	U	Complaint file establishment, Manufacturer	accessdata.fda.gov
Polymer, Ear, Nose And Throat, Synthetic, Absorbable	NHB	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Protective Coating, Mucoadhesive Application, For The Rectal Mucosa	PHN	U	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 3, 2026	K261504	PuraStat-RM	PHN	Substantially Equivalent	3-D Matrix, Inc.	accessdata.fda.gov
August 3, 2026	K261503	PuraStat GI	QAU	Substantially Equivalent	3-D Matrix, Inc.	accessdata.fda.gov
February 28, 2023	K222481	PuraStat	QAU	Substantially Equivalent	3-D Matrix, Inc.	accessdata.fda.gov
April 1, 2022	K213552	PuraStat-RM	PHN	Substantially Equivalent	3-D Matrix, Inc.	accessdata.fda.gov
October 8, 2021	K210211	PuraStat-OM	OLR	Substantially Equivalent	3-D Matrix, Inc.	accessdata.fda.gov
June 25, 2021	K210098	PuraStat-GI	QAU	Substantially Equivalent	3-D Matrix, Inc.	accessdata.fda.gov
April 12, 2019	K183015	PuraSinus	NHB	Substantially Equivalent	3-D Matrix, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
December 2, 2019	89577	Class II	Terminated	PuraSinus Absorbable Nasal Hemostat, Part Numbers	The boxes used by the shipper were not validated for use during transport.	accessdata.fda.gov

Compare with other makers

Updated August 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.