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Custom Medical Specialties, Inc.
CUSTOM ASSEMBLIES, INC. · Model CMS-606 · UDI-DI 00815849020191
0
510(k) clearances
1
Adverse events
1
Recalls
19
Facilities
Description
6mm Reducer Plug - Non-Sterile
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-10-21 | Karl Storz Endoscopy | Due to improper labeling of products. An intended use on the label has not been reviewed and approved by FDA for distribution in the U.S. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.