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Greenwald Surgical Company, Inc.

GRACE MANUFACTURING, INC. · Model 54000-02 · UDI-DI 10801334012014

FHA Prescription
10
510(k) clearances
26
Adverse events
1
Recalls
70
Facilities

Description

Cunningham incontinence clamp, juvenile

Recalls

DateFirmReason
2018-02-16Aesculap Implant Systems LLCThe plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.

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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.