Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Biotech companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in New ZealandLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 6 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list AROA Biosurgery with 24 device recalls and 13 510(k) clearances. The most recent is a 510(k) clearance dated Jun 24, 2026: Endoform Dermal Template.
Device recalls: 24
510(k) clearances: 13
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
22017Records2
2520182018Records25vs 2017+23
12019Records1vs 2018−24
120202020Records1vs 2019+0
12021Records1vs 2020+0
020222022Records0vs 2021−1
12023Records1vs 2022+1
120242024Records1vs 2023+0
12025Records1vs 2024+0
120262026 to dateRecords1
Latest Records
Newest first across sources; each opens the record
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata.How this page is built
