510(k) K140369 ยท HBA Neurosurgical Paddie
MEDLINE NEURO SPONGE
| Applicant | Medline Industries, Inc., Mundelein IL, US |
| Decision | Substantially Equivalent, Sep 26, 2014 |
| Received | Feb 14, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140369
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 30, 2026 | Medline Industries, LP Medline Neuro Sponges, various dimensions, labeled as:
1. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.25" X 0.25", XR, 10/PK, Medline SKU NEUROSPNG02;
2. Neuro Sponges, Eponges neuro, Open, Classified |
HBA | None listed |
| Apr 30, 2026 | Medline Industries, LP Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPNG NEURO 1X1 10/PK XR, Medline Kit Number/SKU DNSC38133 Open, Classified |
HBA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.