AROA Biosurgery, LTD.
FDA Regulatory Profile
AROA Biosurgery, LTD. appears in FDA public data with 24 recalls, 10 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-0378-2019, Class II) was initiated on November 27, 2018. Its most recent 510(k) clearance was granted on June 24, 2026.
Summary
- Total Recalls
- 24
- 510(k) Clearances
- 10
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0378-2019 | Class II | Endoform Dermal Template 2x2, SKU 529312 Product Usage: Endoform Dermal Template is a sterile, s | November 27, 2018 |
| Z-0377-2019 | Class II | Endoform Dermal Template 2x2, SKU 529311 Product Usage: Endoform Dermal Template is a sterile, s | November 27, 2018 |
| Z-0379-2019 | Class II | Endoform Dermal Template 4x5, SKU 529313 Product Usage: Endoform Dermal Template is a sterile, s | November 27, 2018 |
| Z-0425-2019 | Class II | OviTex 1S Reinforced BioScaffold 16x20cm, Part Number F10256-1620G | April 6, 2018 |
| Z-0431-2019 | Class II | OviTex 2S Reinforced BioScaffold 16x20cm, Part Number F10258-1620G | April 6, 2018 |
| Z-0421-2019 | Class II | OviTex 1S Reinforced BioScaffold 4x8cm, Part Number F10256-0408G | April 6, 2018 |
| Z-0432-2019 | Class II | OviTex 2S Reinforced BioScaffold 18x22cm, Part Number F10258-1822G | April 6, 2018 |
| Z-0430-2019 | Class II | OviTex 2S Reinforced BioScaffold 10x20cm, Part Number F10258-1020G | April 6, 2018 |
| Z-0417-2019 | Class II | OviTex Reinforced BioScaffold 10x12cm, Part Number F10254-1012G | April 6, 2018 |
| Z-0416-2019 | Class II | OviTex Reinforced BioScaffold 6x10cm, Part Number F10254-0610G | April 6, 2018 |
| Z-0435-2019 | Class II | OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G | April 6, 2018 |
| Z-0423-2019 | Class II | OviTex 1S Reinforced BioScaffold 10x12cm, Part Number F10256-1012G | April 6, 2018 |
| Z-0426-2019 | Class II | OviTex 1S Reinforced BioScaffold 18x22cm, Part Number F10256-1822G | April 6, 2018 |
| Z-0429-2019 | Class II | OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G | April 6, 2018 |
| Z-0418-2019 | Class II | OviTex Reinforced BioScaffold 10x20cm, Part Number F10254-1020G | April 6, 2018 |
| Z-0415-2019 | Class II | OviTex Reinforced BioScaffold 4x8cm, Part Number F10254-0408G | April 6, 2018 |
| Z-0419-2019 | Class II | OviTex Reinforced BioScaffold 16x20cm, Part Number F10254-1620G | April 6, 2018 |
| Z-0434-2019 | Class II | OviTex Reinforced BioScaffold 18x22cm, Part Number F10254-1822G | April 6, 2018 |
| Z-0424-2019 | Class II | OviTex 1S Reinforced BioScaffold 10x20cm, Part Number F10256-1020G | April 6, 2018 |
| Z-0428-2019 | Class II | OviTex 2S Reinforced BioScaffold 6x10cm, Part Number F10258-0610G | April 6, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K260669 | Endoform Dermal Template | June 24, 2026 |
| K250598 | Endoform Reconstructive Template - PLGA | June 3, 2025 |
| K231305 | Endoform Dental Membrane | January 23, 2024 |
| K223373 | Enivo | April 7, 2023 |
| K200502 | Myriad Particles | March 31, 2021 |
| K200413 | Symphony | July 29, 2020 |
| K183398 | Endoform Restella | April 11, 2019 |
| K181935 | Endoform Reconstructive Template - Non Absorbable | December 4, 2018 |
| K172318 | Endoform Silver Dermal Template | November 17, 2017 |
| K171231 | Endoform Topical Matrix | June 14, 2017 |