Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list CellEra with 6 device recalls. The most recent is a device recall dated Dec 15, 2021: 20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box.
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.
| Date | Record | Source |
|---|---|---|
| Dec 15, 2021 | 20545 Vitale Silver calcium Alginate Dressings 4x5, 10/boxClass III · Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k | Device recalls |
| Dec 15, 2021 | 20522 Vitale Silver calcium Alginate Dressings 2x2, 10/boxClass III · Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k | Device recalls |
| Dec 15, 2021 | 20544 Vitale Silver calcium Alginate Dressings 4x4, 10/boxClass III · Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k | Device recalls |
| Dec 15, 2021 | 20500 Vitale Silver calcium Alginate Dressing Ropes, 5/boxClass III · Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k | Device recalls |
| Dec 15, 2021 | 20548 Vitale Silver calcium Alginate Dressings 4x8, 5/boxClass III · Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k | Device recalls |
| Sep 1, 2016 | VITALE Silicon Foam Dressings 4"x4" Cat. No. 20144Class II · Adhesive border was not sticky enough. | Device recalls |
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
