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A10

BURLINGTON MEDICAL, LLC · Model S3A10-LF · UDI-DI 00840331285482

IWO
1
510(k) clearances
5
Adverse events
13
Recalls
80
Facilities

Description

S3A10-LF, FEMALE (Custom A10: Frontal Apron with crisscross stretch back .35MM STRATA 300, LF)

Recalls

DateFirmReason
2026-02-11Burlington Medical, LLCPotential for attenuation degradation over time, decreasing the lifespan.
2026-02-11Burlington Medical, LLCPotential for attenuation degradation over time, decreasing the lifespan.
2026-02-11Burlington Medical, LLCPotential for attenuation degradation over time, decreasing the lifespan.
2026-02-11Burlington Medical, LLCPotential for attenuation degradation over time, decreasing the lifespan.
2026-02-11Burlington Medical, LLCPotential for attenuation degradation over time, decreasing the lifespan.
2026-02-11Burlington Medical, LLCPotential for attenuation degradation over time, decreasing the lifespan.
2026-02-11Burlington Medical, LLCPotential for attenuation degradation over time, decreasing the lifespan.
2026-02-11Burlington Medical, LLCPotential for attenuation degradation over time, decreasing the lifespan.
2026-02-11Burlington Medical, LLCPotential for attenuation degradation over time, decreasing the lifespan.
2026-02-11Burlington Medical, LLCPotential for attenuation degradation over time, decreasing the lifespan.

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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.