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20/20™

PARKELL, INC. · Model S575 · UDI-DI 10810000526694

EAX Prescription
10
510(k) clearances
47
Adverse events
1
Recalls
375
Facilities

Description

20/20™ Double Sided Mouth Mirrors (Pkg. of 6 pcs.)

Recalls

DateFirmReason
2021-03-23Sunstar Americas, Inc.Product may be contaminated with Burkholderia contaminans.

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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.