AROA Biosurgery, LTD.

FDA Regulatory Profile

Summary

Total Recalls
24
510(k) Clearances
9
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0377-2019Class IIEndoform Dermal Template 2x2, SKU 529311 Product Usage: Endoform Dermal Template is a sterile, sNovember 27, 2018
Z-0379-2019Class IIEndoform Dermal Template 4x5, SKU 529313 Product Usage: Endoform Dermal Template is a sterile, sNovember 27, 2018
Z-0378-2019Class IIEndoform Dermal Template 2x2, SKU 529312 Product Usage: Endoform Dermal Template is a sterile, sNovember 27, 2018
Z-0433-2019Class IIOviTex 2S Reinforced BioScaffold 20x20cm, Part Number F10258-2020GApril 6, 2018
Z-0425-2019Class IIOviTex 1S Reinforced BioScaffold 16x20cm, Part Number F10256-1620GApril 6, 2018
Z-0427-2019Class IIOviTex 1S Reinforced BioScaffold 20x20cm, Part Number F10256-2020GApril 6, 2018
Z-0421-2019Class IIOviTex 1S Reinforced BioScaffold 4x8cm, Part Number F10256-0408GApril 6, 2018
Z-0432-2019Class IIOviTex 2S Reinforced BioScaffold 18x22cm, Part Number F10258-1822GApril 6, 2018
Z-0430-2019Class IIOviTex 2S Reinforced BioScaffold 10x20cm, Part Number F10258-1020GApril 6, 2018
Z-0417-2019Class IIOviTex Reinforced BioScaffold 10x12cm, Part Number F10254-1012GApril 6, 2018
Z-0429-2019Class IIOviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012GApril 6, 2018
Z-0415-2019Class IIOviTex Reinforced BioScaffold 4x8cm, Part Number F10254-0408GApril 6, 2018
Z-0416-2019Class IIOviTex Reinforced BioScaffold 6x10cm, Part Number F10254-0610GApril 6, 2018
Z-0419-2019Class IIOviTex Reinforced BioScaffold 16x20cm, Part Number F10254-1620GApril 6, 2018
Z-0435-2019Class IIOviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012GApril 6, 2018
Z-0434-2019Class IIOviTex Reinforced BioScaffold 18x22cm, Part Number F10254-1822GApril 6, 2018
Z-0422-2019Class IIOviTex 1S Reinforced BioScaffold 6x10cm, Part Number F10256-0610GApril 6, 2018
Z-0424-2019Class IIOviTex 1S Reinforced BioScaffold 10x20cm, Part Number F10256-1020GApril 6, 2018
Z-0426-2019Class IIOviTex 1S Reinforced BioScaffold 18x22cm, Part Number F10256-1822GApril 6, 2018
Z-0431-2019Class IIOviTex 2S Reinforced BioScaffold 16x20cm, Part Number F10258-1620GApril 6, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K250598Endoform Reconstructive Template - PLGAJune 3, 2025
K231305Endoform Dental MembraneJanuary 23, 2024
K223373Enivo™April 7, 2023
K200502Myriad ParticlesMarch 31, 2021
K200413SymphonyJuly 29, 2020
K183398Endoform RestellaApril 11, 2019
K181935Endoform Reconstructive Template - Non AbsorbableDecember 4, 2018
K172318Endoform Silver Dermal TemplateNovember 17, 2017
K171231Endoform Topical MatrixJune 14, 2017