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REMEL, INC. · Model R21502 · UDI-DI 00848838023743

JFO
1
510(k) clearances
1
Adverse events
1
Recalls
4
Facilities

Recalls

DateFirmReason
2024-09-20Remel, IncA color change of the solution within the dropper can occur from orange-yellow to light yellow resulting in out-of-specification fluorescent stain results.

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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.