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Quantum

SPECTRUM MEDICAL LIMITED · Model 52-000096-00 · UDI-DI 05060434423832

DTX Prescription
1
510(k) clearances
771
Adverse events (3 deaths)
0
Recalls
3
Facilities

Description

IRMA Adaptor Kit

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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.