510(k) K830269 ยท EFQ Gauze/Sponge, Internal
FLORET NEURO SPONGE
| Applicant | Ritmed, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jun 2, 1983 |
| Received | Jan 25, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K830269
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 16, 2026 | AMD Medicom Inc. Ritmed Neurological Sponges, Description/REF:
0.5x0.5in, Non-Sterile/55992C;
0.5x1.0in, Non-Sterile/55993C;
0.5x3.0in, Non-Sterile/55994C;
0.75x0.75in, Non-Sterile/55995C;
1.0x1.0in, Non-Sterile/ Open, Classified |
EFQ | None listed |
| Jun 16, 2026 | AMD Medicom Inc. Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C Open, Classified |
EFQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.