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HEINE OMEGA 180

SONTEC INSTRUMENTS, INC. · Model C-004.33.226 · UDI-DI 00192896009486

HJI Prescription
1
510(k) clearances
13
Adverse events
1
Recalls
10
Facilities

Description

HEINE - OMEGA 180 WITH EN15 AND TRANSFORMER

Recalls

DateFirmReason
2015-02-27Volk Optical IncMislabeling. The incorrect lot number was engraved on the anodized aluminum ring. The correct lot number is BE03356; however, BD03356 was engraved on the ring in error.

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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.