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Oleeva Fabric Breast Areola

Bio Med Sciences, Inc. · Model 37BA · UDI-DI 00810050460484

MDA
10
510(k) clearances
51
Adverse events (1 deaths)
0
Recalls
190
Facilities

Description

Silicone Gel Sheeting bonded with Fabric

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data 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.