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KaWe

BV Medical · Model 61-911-110 · UDI-DI 00845821020901

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

Description

Specula, Disposable, 4.0mm (100 per pack, green)

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.