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MAMMOGRAM ROBE

STANDARD TEXTILE CO., INC. · Model 74M58081 · UDI-DI 00634916226782

FME
5
510(k) clearances
15
Adverse events (1 deaths)
1
Recalls
238
Facilities

Description

MAMMOGRAM ROBE HEALING SPACES KAUM RM (98 8046) USE: 74767081

Recalls

DateFirmReason
2009-12-23Encompass Group LLCThe products are not compatible for use in the Magnetic Resonance Imaging (MRI) environment.

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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.