Aroa Biosurgery
Aroa Biosurgery holds FDA 510(k) medical device clearances, cleared in 2017, with 3 FDA device recalls on record.
Top product codes for Aroa Biosurgery
FDA recalls by Aroa Biosurgery
- Z-0378-2019 — 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 wound environment.
- Z-0377-2019 — 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 wound environment.
- Z-0379-2019 — 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 wound environment.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.