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PENTAX OF AMERICA, INC. · Model 7194-1000 · UDI-DI 04961333231607

KLX Prescription
4
510(k) clearances
1
Adverse events
0
Recalls
2
Facilities

Description

CD,5109 REV.A V 3.4.1

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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.