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andorate® Universal Endoscope Tip Guard

GA Health Company Limited · Model GAR107 · UDI-DI 04897106953547

OCU Prescription
6
510(k) clearances
1
Adverse events
1
Recalls
9
Facilities

Recalls

DateFirmReason
2026-03-12Healthmark Industries Co., Inc.Product does not have FDA clearance.

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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.