Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Oculo-Plastik and its 1 subsidiaries with 14 510(k) clearances and 1 warning letter. The most recent is a warning letter dated May 8, 2017: Warning letter: Drugs.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Oculo-Plastik and its 1 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| May 8, 2017 | Warning letter: DrugsCDRH | Warning letters |
| Jan 31, 2013 | DURETTE OCULAR IMPLANTK123764 · HPZ | 510(k) clearances |
| Sep 15, 2011 | SILICONE SPHERESK112176 · HPZ | 510(k) clearances |
| Mar 19, 2008 | DURETTE IMPLANTK073293 · HPZ | 510(k) clearances |
| Jun 10, 2004 | EYE SPHERE IMPLANTSK040689 · HPZ | 510(k) clearances |
| May 5, 1994 | EPTFE SHEET COVERING FOR OCULAR IMPLANTK934834 · HPZ | 510(k) clearances |
| Mar 2, 1992 | OPHTIMPLANTK915630 · HPZ | 510(k) clearances |
| May 22, 1990 | O'DONNELL, SOCKET RECONSTRUCTION PROSTHESESK901002 · HQX | 510(k) clearances |
| May 18, 1990 | PUTTERMAN-SCOTT, SOCKET RECONSTRUCTION BILATERALK900929 · HQX | 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
