Aroa Biosurgery Limited (Formerly Mesynthes Limited) FDA Record
Aroa Biosurgery Limited (Formerly Mesynthes Limited) has 0 FDA recalls, 0 inspections, 2 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Aroa Biosurgery Limited (Formerly Mesynthes Limited)" is on file.
- Latest 510(k)
- Jun 16, 2016
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 2 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 0 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K153632 | Endoform Reconstructive Template | Jun 16, 2016 |
| K153633 | Endoform Reconstructive Template | Mar 15, 2016 |
Aroa Biosurgery Limited (Formerly Mesynthes Limited) and the FDA: common questions
Has Aroa Biosurgery Limited (Formerly Mesynthes Limited) received an FDA warning letter?
No FDA warning letter addressed to the name "Aroa Biosurgery Limited (Formerly Mesynthes Limited)" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Aroa Biosurgery Limited (Formerly Mesynthes Limited) received an FDA Form 483?
FDA has not published a Form 483 for "Aroa Biosurgery Limited (Formerly Mesynthes Limited)" in its reading room. FDA publishes some Form 483s, not all of them.
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