AROA Biosurgery, LTD.
Medical device manufacturer in Auckland, NZ.
10510(k) clearances
0PMA approvals
24recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K260669 | Endoform Dermal TemplateKGN · Traditional | 06/24/2026SE |
| K250598 | Endoform Reconstructive Template - PLGAFTM · Traditional | 06/03/2025SE |
| K231305 | Endoform Dental MembraneNPL · Traditional | 01/23/2024SE |
| K223373 | EnivoBTA · Traditional | 04/07/2023SE |
| K200502 | Myriad ParticlesKGN · Traditional | 03/31/2021SE |
| K200413 | SymphonyKGN · Traditional | 07/29/2020SE |
| K183398 | Endoform RestellaFTM · Traditional | 04/11/2019SE |
| K181935 | Endoform Reconstructive Template - Non AbsorbableFTL · Traditional | 12/04/2018SE |
| K172318 | Endoform Silver Dermal TemplateFRO · Traditional | 11/17/2017SE |
| K171231 | Endoform Topical MatrixKGN · Traditional | 06/14/2017SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0379-2019 Class II | Endoform Dermal Template 4x5, SKU 529313 Product Usage: Endoform Dermal Template is a…Potential for pouch seal failure | 11/27/2018Terminated |
| Z-0378-2019 Class II | Endoform Dermal Template 2x2, SKU 529312 Product Usage: Endoform Dermal Template is a…Potential for pouch seal failure | 11/27/2018Terminated |
| Z-0377-2019 Class II | Endoform Dermal Template 2x2, SKU 529311 Product Usage: Endoform Dermal Template is a…Potential for pouch seal failure | 11/27/2018Terminated |
| Z-0435-2019 Class II | OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | 04/06/2018Terminated |
| Z-0434-2019 Class II | OviTex Reinforced BioScaffold 18x22cm, Part Number F10254-1822GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | 04/06/2018Terminated |
| Z-0433-2019 Class II | OviTex 2S Reinforced BioScaffold 20x20cm, Part Number F10258-2020GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | 04/06/2018Terminated |
| Z-0432-2019 Class II | OviTex 2S Reinforced BioScaffold 18x22cm, Part Number F10258-1822GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | 04/06/2018Terminated |
| Z-0431-2019 Class II | OviTex 2S Reinforced BioScaffold 16x20cm, Part Number F10258-1620GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | 04/06/2018Terminated |
| Z-0430-2019 Class II | OviTex 2S Reinforced BioScaffold 10x20cm, Part Number F10258-1020GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | 04/06/2018Terminated |
| Z-0429-2019 Class II | OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | 04/06/2018Terminated |
| Z-0428-2019 Class II | OviTex 2S Reinforced BioScaffold 6x10cm, Part Number F10258-0610GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | 04/06/2018Terminated |
| Z-0427-2019 Class II | OviTex 1S Reinforced BioScaffold 20x20cm, Part Number F10256-2020GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | 04/06/2018Terminated |
| Z-0426-2019 Class II | OviTex 1S Reinforced BioScaffold 18x22cm, Part Number F10256-1822GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | 04/06/2018Terminated |
| Z-0425-2019 Class II | OviTex 1S Reinforced BioScaffold 16x20cm, Part Number F10256-1620GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | 04/06/2018Terminated |
| Z-0424-2019 Class II | OviTex 1S Reinforced BioScaffold 10x20cm, Part Number F10256-1020GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | 04/06/2018Terminated |
| Z-0423-2019 Class II | OviTex 1S Reinforced BioScaffold 10x12cm, Part Number F10256-1012GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | 04/06/2018Terminated |
| Z-0422-2019 Class II | OviTex 1S Reinforced BioScaffold 6x10cm, Part Number F10256-0610GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | 04/06/2018Terminated |
| Z-0421-2019 Class II | OviTex 1S Reinforced BioScaffold 4x8cm, Part Number F10256-0408GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | 04/06/2018Terminated |
| Z-0420-2019 Class II | OviTex Reinforced BioScaffold 20x20cm, Part Number F10254-2020GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | 04/06/2018Terminated |
| Z-0419-2019 Class II | OviTex Reinforced BioScaffold 16x20cm, Part Number F10254-1620GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | 04/06/2018Terminated |
| Z-0418-2019 Class II | OviTex Reinforced BioScaffold 10x20cm, Part Number F10254-1020GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | 04/06/2018Terminated |
| Z-0417-2019 Class II | OviTex Reinforced BioScaffold 10x12cm, Part Number F10254-1012GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | 04/06/2018Terminated |
| Z-0416-2019 Class II | OviTex Reinforced BioScaffold 6x10cm, Part Number F10254-0610GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | 04/06/2018Terminated |
| Z-0415-2019 Class II | OviTex Reinforced BioScaffold 4x8cm, Part Number F10254-0408GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | 04/06/2018Terminated |