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BioSentry®

Merit Medical Systems, Inc. · Model A · UDI-DI 00884450808122

OMT Prescription
2
510(k) clearances
46
Adverse events
1
Recalls
10
Facilities

Recalls

DateFirmReason
2016-09-24Surgical Specialties Mexico S DE RL DE CVSurgical Specialties Mexico is recalling the BioSentry Track Sealant System due to the potential for an open seal on the product package.

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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.