510(k) K972661 ยท HPZ Implant, Eye Sphere
EYE SPHERE, CONFORMERS
| Applicant | Gulden Ophthalmics, Elkins Park PA, US |
| Decision | Substantially Equivalent, Oct 3, 1997 |
| Received | Jul 16, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972661
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 5, 2003 | Gulden Ophthalmics Venus Eye sphere 10 mm (Sterile) Terminated |
HQX | None listed |
| Feb 5, 2003 | Gulden Ophthalmics Venus Eye Sphere 12 mm (Sterile) Terminated |
HQX | None listed |
| Feb 5, 2003 | Gulden Ophthalmics Venus Eye Sphere 14 mm (Sterile) Terminated |
HQX | None listed |
| Feb 5, 2003 | Gulden Ophthalmics Venus Eye Sphere 16 mm (Sterile) Terminated |
HQX | None listed |
| Feb 5, 2003 | Gulden Ophthalmics Venus Eye Sphere 18 mm (Sterile) Terminated |
HQX | None listed |
| Feb 5, 2003 | Gulden Ophthalmics Venus Eye Sphere 20 mm (Sterile) Terminated |
HQX | None listed |
| Feb 5, 2003 | Gulden Ophthalmics Venus Eye Sphere 22 mm (Sterile) Terminated |
HQX | None listed |
| Feb 5, 2003 | Gulden Ophthalmics Conformer - Small (Sterile) Terminated |
HQX | None listed |
| Feb 5, 2003 | Gulden Ophthalmics Conformer - Medium (Sterile) Terminated |
HQX | None listed |
| Feb 5, 2003 | Gulden Ophthalmics Conformer - Large (Sterile) Terminated |
HQX | None listed |
| Feb 5, 2003 | Gulden Ophthalmics Conformer - Small with holes (Sterile) Terminated |
HQX | None listed |
| Feb 5, 2003 | Gulden Ophthalmics Conformer - Medium with holes (Sterile) Terminated |
HQX | None listed |
| Feb 5, 2003 | Gulden Ophthalmics Conformer - Large with holes (Sterile) Terminated |
HQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.