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Prolaryn Gel

MERZ NORTH AMERICA, INC. · Model 1.0 cc · UDI-DI 00810235030846

MIX Prescription
1
510(k) clearances
41
Adverse events
1
Recalls
10
Facilities

Description

Prolaryn Gel is a temporary, injectable, carboxymethylcellulose-based implant designed to treat vocal fold insufficiency (such as paralysis) by augmenting or "bulking" the vocal fold for improved voice production.

Recalls

DateFirmReason
2015-10-26Merz North America, Inc.The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.

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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.