Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Acera Surgical, Inc. with 8 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Oct 16, 2026: Restrata.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 16, 2026 | RestrataK261245 · QSZ | 510(k) clearances |
| Jun 20, 2025 | Restrata Soft Tissue Reinforcement (STR)K251224 · OXF | 510(k) clearances |
| May 18, 2023 | Restrata® MiniMatrixK223725 · QSZ | 510(k) clearances |
| Mar 21, 2022 | Restrata, Part Number RWM1-2X2Class II · Misprinted expiration date on the shelf-box | Device recalls |
| Sep 25, 2020 | Restrata®K193583 · QSZ | 510(k) clearances |
| Nov 27, 2017 | Cerafix Dura SubstituteK172603 · GXQ | 510(k) clearances |
| Apr 26, 2017 | Restrata Wound MatrixK170300 · QSZ | 510(k) clearances |
| Aug 8, 2016 | Cerafix Dura SubstituteK161278 · GXQ | 510(k) clearances |
| Mar 16, 2016 | Cerafix Dura SubstituteK153613 · GXQ | 510(k) clearances |
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
