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DeRoyal

DEROYAL INDUSTRIES, INC. · Model HD-395-1000-RDEU · UDI-DI 00749756838245

FNY
9
510(k) clearances
11
Adverse events
1
Recalls
224
Facilities

Description

SPONGE BOWL - RED

Recalls

DateFirmReason
2023-05-30DeRoyal Industries IncThe outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.

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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.