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SPECTRALIS

Heidelberg Engineering GmbH · Model Software V.7.2-US · UDI-DI 04059237001027

MYCOBO Prescription
2
510(k) clearances
4
Adverse events (2 deaths)
0
Recalls
14
Facilities

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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.