Company · NZ
AROA Biosurgery, LTD.
FDA 510(k) clearances and medical device recalls filed under this name, 2017 to 2026. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (1 in 12 months)
24recalls (0 in 12 months)
24recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 24, 2026 | K260669 | Endoform Dermal Template Aroa Biosurgery , Ltd., NZ | KGN |
| Jun 3, 2025 | K250598 | Endoform Reconstructive Template - PLGA Aroa Biosurgery , Ltd., NZ | FTM |
| Jan 23, 2024 | K231305 | Endoform Dental Membrane Aroa Biosurgery , Ltd., NZ | NPL |
| Apr 7, 2023 | K223373 | Enivo Aroa Biosurgery , Ltd., NZ | BTA |
| Mar 31, 2021 | K200502 | Myriad Particles Aroa Biosurgery , Ltd., NZ | KGN |
| Jul 29, 2020 | K200413 | Symphony Aroa Biosurgery , Ltd., NZ | KGN |
| Apr 11, 2019 | K183398 | Endoform Restella Aroa Biosurgery , Ltd., NZ | FTM |
| Dec 4, 2018 | K181935 | Endoform Reconstructive Template - Non Absorbable Aroa Biosurgery , Ltd., NZ | FTL |
| Nov 17, 2017 | K172318 | Endoform Silver Dermal Template Aroa Biosurgery, NZ | FRO |
| Jun 14, 2017 | K171231 | Endoform Topical Matrix Aroa Biosurgery, NZ | KGN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 2, 2018 | AROA BIOSURGERY Endoform Dermal Template 4x5, SKU 529313
Product Usage:
Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist Terminated |
KGN | K092096 |
| Nov 2, 2018 | AROA BIOSURGERY Endoform Dermal Template 2x2, SKU 529312
Product Usage:
Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist Terminated |
KGN | K092096 |
| Nov 2, 2018 | AROA BIOSURGERY 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 Terminated |
KGN | K092096 |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G Terminated |
FTM | K153633 |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex Reinforced BioScaffold 18x22cm, Part Number F10254-1822G Terminated |
FTM | K153633 |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex 2S Reinforced BioScaffold 20x20cm, Part Number F10258-2020G Terminated |
FTM | K153633 |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex 2S Reinforced BioScaffold 18x22cm, Part Number F10258-1822G Terminated |
FTM | K153633 |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex 2S Reinforced BioScaffold 16x20cm, Part Number F10258-1620G Terminated |
FTM | K153633 |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex 2S Reinforced BioScaffold 10x20cm, Part Number F10258-1020G Terminated |
FTM | K153633 |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G Terminated |
FTM | K153633 |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex 2S Reinforced BioScaffold 6x10cm, Part Number F10258-0610G Terminated |
FTM | K153633 |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex 1S Reinforced BioScaffold 20x20cm, Part Number F10256-2020G Terminated |
FTM | K153633 |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex 1S Reinforced BioScaffold 18x22cm, Part Number F10256-1822G Terminated |
FTM | K153633 |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex 1S Reinforced BioScaffold 16x20cm, Part Number F10256-1620G Terminated |
FTM | K153633 |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex 1S Reinforced BioScaffold 10x20cm, Part Number F10256-1020G Terminated |
FTM | K153633 |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex 1S Reinforced BioScaffold 10x12cm, Part Number F10256-1012G Terminated |
FTM | K153633 |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex 1S Reinforced BioScaffold 6x10cm, Part Number F10256-0610G Terminated |
FTM | K153633 |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex 1S Reinforced BioScaffold 4x8cm, Part Number F10256-0408G Terminated |
FTM | K153633 |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex Reinforced BioScaffold 20x20cm, Part Number F10254-2020G Terminated |
FTM | K153633 |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex Reinforced BioScaffold 16x20cm, Part Number F10254-1620G Terminated |
FTM | K153633 |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex Reinforced BioScaffold 10x20cm, Part Number F10254-1020G Terminated |
FTM | K153633 |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex Reinforced BioScaffold 10x12cm, Part Number F10254-1012G Terminated |
FTM | K153633 |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex Reinforced BioScaffold 6x10cm, Part Number F10254-0610G Terminated |
FTM | K153633 |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex Reinforced BioScaffold 4x8cm, Part Number F10254-0408G Terminated |
FTM | K153633 |