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Aroa Biosurgery

Last updated May 24, 2026

Information

Country: US
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Catalogue (146)

Page 3 of 3

Device	Model / Reference	Registries	Class	Status
Endoform Myriad	MR05LG0505	FDA UDI	U	Unknown
Endoform™ Antimicrobial Restorative Bioscaffold	629313	FDA UDI	U	Active
Endoform Antimicrobial Dermal Template	629304	FDA UDI	U	Active
Endoform Natural Dermal Template	529311	FDA UDI	U	Active
Ovitex® PRS	R20353-2022G	FDA UDI	Class II	Unknown
Restella	R20343-2022P	FDA UDI	Class II	Unknown
Myriad Matrix™ Soft Tissue Bioscaffold	SR05LG1010US	FDA UDI	U	Active
Myriad Matrix™ Soft Tissue Bioscaffold	SR05LG0505US	FDA UDI	U	Active
Myriad Matrix™ Soft Tissue Bioscaffold	SR05LG0710US	FDA UDI	U	Active
Ovitex® PRS	R20343-1622P	FDA UDI	Class II	Unknown
Symphony™ Proliferative Bioscaffold	CM03HA006R	FDA UDI	U	Active
Myriad Morcells™	PW01NA2000	FDA UDI	U	Unknown
Restella	R20243-0717P	FDA UDI	Class II	Unknown
Symphony™ Proliferative Bioscaffold	CM04HA1010	FDA UDI	U	Active
Restella	R20143-0416P	FDA UDI	Class II	Unknown
OviTex® IHR	F10244-1017I	FDA UDI	Class II	Active
Ovitex® PRS	R20253-0815G	FDA UDI	Class II	Unknown
Myriad Matrix™ Soft Tissue Bioscaffold	SR05LG1020US	FDA UDI	U	Active
Ovitex® PRS	R20253-1020G	FDA UDI	Class II	Unknown
Ovitex® PRS	R20143-1620P	FDA UDI	Class II	Unknown
Endoform Surface	SR03LG1010	FDA UDI	U	Unknown
Symphony™ Proliferative Bioscaffold	CM03HA006S	FDA UDI	U	Active
Ovitex® PRS	R20243-1020P	FDA UDI	Class II	Unknown
Restella	R20253-0717G	FDA UDI	Class II	Unknown
Symphony™ Proliferative Bioscaffold	CM03HA009S	FDA UDI	U	Unknown
Endoform Antimicrobial Dermal Template	629311	FDA UDI	U	Active
Endoform™ Antimicrobial Restorative Bioscaffold	629315	FDA UDI	U	Active
Restella	R20353-1622G	FDA UDI	Class II	Unknown
Myriad Matrix™ Soft Tissue Bioscaffold	SR03LG1010US	FDA UDI	U	Active
Symphony™ Proliferative Bioscaffold	CM03HA012R	FDA UDI	U	Active
Symphony™ Proliferative Bioscaffold	CM03HA035R	FDA UDI	U	Unknown
Endoform™ Natural Restorative Bioscaffold	529312	FDA UDI	U	Active
Ovitex® PRS	R20153-0820G	FDA UDI	Class II	Unknown
Endoform Natural Dermal Template	529314	FDA UDI	U	Active
Ovitex® PRS	R30353-2025G	FDA UDI	Class II	Unknown
Ovitex® PRS	R30343-1622P	FDA UDI	Class II	Unknown
OviTex® IHR	F10243-1017I	FDA UDI	Class II	Active
Symphony™ Proliferative Bioscaffold	CM04HA0202	FDA UDI	U	Active
Endoform Natural Dermal Template	529312	FDA UDI	U	Active
Endoform Natural Dermal Template	529313	FDA UDI	U	Active
Ovitex® PRS	R20243-1122P	FDA UDI	Class II	Unknown
Myriad Matrix™ Soft Tissue Bioscaffold	SR03LG2020US	FDA UDI	U	Active
Endoform Myriad	MR03LG1010	FDA UDI	U	Unknown
Ovitex® PRS	R30343-2025P	FDA UDI	Class II	Unknown
Endoform Topical Matrix	K171231	FDA 510(k)	U	Active
Endoform Silver Dermal Template	K172318	FDA 510(k)	U	Active

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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.