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MAMMOGRAM CAPE
STANDARD TEXTILE CO., INC. · Model 74405480 · UDI-DI 00634916677805
5
510(k) clearances
7
Adverse events (1 deaths)
1
Recalls
237
Facilities
Description
Mammography Cape. Front Closure, 3/4 Length Sleeves Set In, White Bias Binding, White Twill Ties at Waist on Inside and Outside, OSFA
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2009-12-23 | Encompass Group LLC | The products are not compatible for use in the Magnetic Resonance Imaging (MRI) environment. |
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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.