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AESCULAP

AESCULAP, INC. · Model MA606R · UDI-DI 04046964588761

FXG Prescription
1
510(k) clearances
4
Adverse events
1
Recalls
37
Facilities

Description

SHEA SPECULUM HOLDER 299MM

Recalls

DateFirmReason
2022-02-28Integra LifeSciences Corp.Excess force used to tighten the Universal Flexible Arm can cause the internal cable to break at the tip, resulting in an unusable condition.

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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.