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Aroa Biosurgery

Last updated May 24, 2026

Information

Country: US
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Catalogue (146)

Page 1 of 3

Device	Model / Reference	Registries	Class	Status
Myriad Morcells™	PW02NA0100	FDA UDI	U	Active
Symphony™ Proliferative Bioscaffold	CM03HA100S	FDA UDI	U	Unknown
Endoform Surface	SR05LG1020	FDA UDI	U	Unknown
Endoform™ Natural Restorative Bioscaffold	529313	FDA UDI	U	Active
Endoform™ Antimicrobial Restorative Bioscaffold	629304	FDA UDI	U	Active
Endoform Natural Dermal Template	529302	FDA UDI	U	Active
Endoform Myriad	MR03LG1020	FDA UDI	U	Unknown
Restella	R20153-0416G	FDA UDI	Class II	Unknown
Endoform™ Antimicrobial Restorative Bioscaffold	629311	FDA UDI	U	Active
Myriad Morcells™	PW02NA0500	FDA UDI	U	Active
Myriad Morcells™	PW01NA0500	FDA UDI	U	Active
Endoform Natural Dermal Template	529315	FDA UDI	U	Active
Ovitex® PRS	R30353-1622G	FDA UDI	Class II	Unknown
Symphony™ Proliferative Bioscaffold	CM03HA004S	FDA UDI	U	Active
Restella	R20143-2020P	FDA UDI	Class II	Unknown
Endoform Antimicrobial Dermal Template	629302	FDA UDI	U	Active
Myriad Matrix™ Soft Tissue Bioscaffold	SR02LG0710US	FDA UDI	U	Active
Restella	R20243-1122P	FDA UDI	Class II	Unknown
Myriad Morcells™	PW01NA1000	FDA UDI	U	Active
Endoform Antimicrobial Dermal Template	629312	FDA UDI	U	Active
Ovitex® PRS	R30343-2022P	FDA UDI	Class II	Unknown
Endoform™ Natural Restorative Bioscaffold	529304	FDA UDI	U	Active
Restella	R20153-2020G	FDA UDI	Class II	Unknown
Ovitex® PRS	R20153-1620G	FDA UDI	Class II	Unknown
Ovitex® PRS	R20143-0820P	FDA UDI	Class II	Unknown
Restella	R30343-1622P	FDA UDI	Class II	Unknown
Symphony™ Proliferative Bioscaffold	CM03HA048R	FDA UDI	U	Unknown
Ovitex® PRS	R20353-2022G	FDA UDI	Class II	Unknown
Restella	R20253-0815G	FDA UDI	Class II	Unknown
Symphony™ Proliferative Bioscaffold	CM03HA002D	FDA UDI	U	Active
Myriad Morcells™	PW02NA1000	FDA UDI	U	Active
Restella	R20243-1018P	FDA UDI	Class II	Unknown
Symphony™ Proliferative Bioscaffold	CM03HA008R	FDA UDI	U	Unknown
Ovitex® PRS	R20343-2025P	FDA UDI	Class II	Unknown
Symphony™ Proliferative Bioscaffold	CM03HA025S	FDA UDI	U	Active
Endoform™ Antimicrobial Restorative Bioscaffold	629314	FDA UDI	U	Active
Symphony™ Proliferative Bioscaffold	CM03HA050R	FDA UDI	U	Active
Restella	R30353-2022G	FDA UDI	Class II	Unknown
Endoform Myriad	MR03LG0505	FDA UDI	Class II	Unknown
Symphony™ Proliferative Bioscaffold	CM03HA016S	FDA UDI	U	Active
Endoform™ Antimicrobial Restorative Bioscaffold	629312	FDA UDI	U	Active
Myriad Morcells™	PW02NA2000	FDA UDI	U	Unknown
Endoform™ Antimicrobial Restorative Bioscaffold	629302	FDA UDI	U	Active
Ovitex® PRS	R20253-1018G	FDA UDI	Class II	Unknown
Endoform Myriad	MR05LG1020	FDA UDI	U	Unknown
Myriad Matrix™ Soft Tissue Bioscaffold	SR02LG1010US	FDA UDI	U	Active
Myriad Morcells™	PW02NA0200	FDA UDI	U	Active
Myriad Ultra™ Reinforced BioScaffold – Permanent (PP)	LP04PP1520	FDA UDI	Class II	Unknown
Ovitex® PRS	R20243-0717P	FDA UDI	Class II	Unknown
Ovitex® PRS	R20243-0815P	FDA UDI	Class II	Unknown

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FDA Recalls (21)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Apr 6, 2018	Z-0417-2019	—	terminated	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.
Apr 6, 2018	Z-0429-2019	—	terminated	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.
Apr 6, 2018	Z-0419-2019	—	terminated	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.
Apr 6, 2018	Z-0422-2019	—	terminated	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.
Apr 6, 2018	Z-0420-2019	—	terminated	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.
Apr 6, 2018	Z-0433-2019	—	terminated	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.
Apr 6, 2018	Z-0415-2019	—	terminated	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.
Apr 6, 2018	Z-0431-2019	—	terminated	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.
Apr 6, 2018	Z-0423-2019	—	terminated	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.
Apr 6, 2018	Z-0421-2019	—	terminated	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.
Apr 6, 2018	Z-0425-2019	—	terminated	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.
Apr 6, 2018	Z-0428-2019	—	terminated	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.
Apr 6, 2018	Z-0432-2019	—	terminated	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.
Apr 6, 2018	Z-0426-2019	—	terminated	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.
Apr 6, 2018	Z-0416-2019	—	terminated	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.
Apr 6, 2018	Z-0434-2019	—	terminated	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.
Apr 6, 2018	Z-0418-2019	—	terminated	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.
Apr 6, 2018	Z-0427-2019	—	terminated	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.
Apr 6, 2018	Z-0435-2019	—	terminated	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.
Apr 6, 2018	Z-0424-2019	—	terminated	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.
Apr 6, 2018	Z-0430-2019	—	terminated	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.