Aroa Biosurgery , Ltd.
Aroa Biosurgery , Ltd. holds FDA 510(k) medical device clearances, first cleared 2018, most recent 2026, with 21 FDA device recalls on record.
Top product codes for Aroa Biosurgery , Ltd.
FDA recalls by Aroa Biosurgery , Ltd.
10 most recent of 21- Z-0428-2019 — OviTex 2S Reinforced BioScaffold 6x10cm, Part Number F10258-0610G
- Z-0423-2019 — OviTex 1S Reinforced BioScaffold 10x12cm, Part Number F10256-1012G
- Z-0433-2019 — OviTex 2S Reinforced BioScaffold 20x20cm, Part Number F10258-2020G
- Z-0420-2019 — OviTex Reinforced BioScaffold 20x20cm, Part Number F10254-2020G
- Z-0425-2019 — OviTex 1S Reinforced BioScaffold 16x20cm, Part Number F10256-1620G
- Z-0429-2019 — OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G
- Z-0418-2019 — OviTex Reinforced BioScaffold 10x20cm, Part Number F10254-1020G
- Z-0415-2019 — OviTex Reinforced BioScaffold 4x8cm, Part Number F10254-0408G
- Z-0421-2019 — OviTex 1S Reinforced BioScaffold 4x8cm, Part Number F10256-0408G
- Z-0419-2019 — OviTex Reinforced BioScaffold 16x20cm, Part Number F10254-1620G
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Aroa Biosurgery , Ltd.
Data sourced from openFDA. This site is unofficial and independent of the FDA.