Data / Medical devices / New Zealand / Aroa Biosurgery Ltd

Aroa Biosurgery Ltd: FDA-registered device maker in Airport Oaks Auckland, New Zealand, 13 510(k) clearances

Name: Aroa Biosurgery Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Aroa Biosurgery Ltd is registered with the FDA (registration 3007321028) in Airport Oaks Auckland, New Zealand. It lists 6 device types. The FDA files 13 510(k) clearances under its listings, the newest dated June 24, 2026. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3007321028
Address: 2 Kingsford Smith Place, Airport Oaks Auckland, New Zealand, 2022
Owner or operator: Aroa Biosurgery Ltd (10028943)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer
First device listed: February 14, 2010
Registered through: 2026
Brand names listed: Aroa Dental Membrane, Endoform Antimicrobial Restorative Bioscaffold, Endoform Dental Membrane, Endoform Natural Restorative Bioscaffold, Myriad Matrix Restore, Myriad Matrix Soft Tissue Bioscaffold, Myriad Meshed, Myriad Morcells and more

Devices it lists

Device	Product code	Class	Role	Source
Barrier, Animal Source, Intraoral	NPL	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Bone Grafting Material, Animal Source	NPM	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Dressing, Wound, Drug	FRO	U	Complaint file establishment, Manufacturer	accessdata.fda.gov
Mesh, Surgical	FTM	2	Complaint file establishment, Contract manufacturer, Manufacturer	accessdata.fda.gov
Mesh, Surgical, Polymeric	FTL	2	Complaint file establishment, Contract manufacturer, Manufacturer	accessdata.fda.gov
Wound Dressing With Animal-Derived Material(S)	KGN	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
June 24, 2026	K260669	Endoform Dermal Template	KGN	Substantially Equivalent	Aroa Biosurgery , Ltd.	accessdata.fda.gov
June 3, 2025	K250598	Endoform Reconstructive Template - PLGA	FTM	Substantially Equivalent	Aroa Biosurgery , Ltd.	accessdata.fda.gov
January 23, 2024	K231305	Endoform Dental Membrane	NPL	Substantially Equivalent	Aroa Biosurgery , Ltd.	accessdata.fda.gov
March 31, 2021	K200502	Myriad Particles	KGN	Substantially Equivalent	Aroa Biosurgery , Ltd.	accessdata.fda.gov
July 29, 2020	K200413	Symphony	KGN	Substantially Equivalent	Aroa Biosurgery , Ltd.	accessdata.fda.gov
December 4, 2018	K181935	Endoform Reconstructive Template - Non Absorbable	FTL	Substantially Equivalent	Aroa Biosurgery , Ltd.	accessdata.fda.gov
November 17, 2017	K172318	Endoform Silver Dermal Template	FRO	Substantially Equivalent	Aroa Biosurgery	accessdata.fda.gov
June 14, 2017	K171231	Endoform Topical Matrix	KGN	Substantially Equivalent	Aroa Biosurgery	accessdata.fda.gov
December 20, 2016	K162461	Endoform Plastics and Reconstructive Matrix	FTM	Substantially Equivalent	Aroa Biosurgery (Formerly Mesynthes Limited)	accessdata.fda.gov
June 16, 2016	K153632	Endoform Reconstructive Template	FTL	Substantially Equivalent	Aroa Biosurgery Limited (Formerly Mesynthes Limited)	accessdata.fda.gov
March 15, 2016	K153633	Endoform Reconstructive Template	FTM	Substantially Equivalent	Aroa Biosurgery Limited (Formerly Mesynthes Limited)	accessdata.fda.gov
May 31, 2013	K130547	ENDOFORM RECONSTRUCTIVE TEMPLATE	FTM	Substantially Equivalent	Mesynthe, Ltd.	accessdata.fda.gov
January 21, 2010	K092096	ENDOFORM DERMAL TEMPLATE	KGN	Substantially Equivalent	Mesynthes, Ltd.	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
November 27, 2018	81161	Class II	Terminated	Endoform Dermal Template 2x2, SKU 529311 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist wound environment.	Potential for pouch seal failure	accessdata.fda.gov
April 6, 2018	81166	Class II	Terminated	OviTex Reinforced BioScaffold 4x8cm, Part Number F10254-0408G	Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.	accessdata.fda.gov

Compare with other makers

Updated June 24, 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.