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Omnia Medical TiBrid™- A/SA

OMNIA MEDICAL, LLC · Model 17-5A-BT14 · UDI-DI 00843511123147

GCZ Prescription
5
510(k) clearances
39
Adverse events
6
Recalls
50
Facilities

Description

TiBrid™-SA Bullet Trial, 14mm

Recalls

DateFirmReason
2025-08-21Folsom Metal Products, Inc.Labeling includes shelf life that has not been validated.
2025-08-21Folsom Metal Products, Inc.Labeling includes shelf life that has not been validated.
2025-08-21Folsom Metal Products, Inc.Labeling includes shelf life that has not been validated.
2025-08-21Folsom Metal Products, Inc.Labeling includes shelf life that has not been validated.
2025-08-21Folsom Metal Products, Inc.Labeling includes shelf life that has not been validated.
2025-08-21Folsom Metal Products, Inc.Labeling includes shelf life that has not been validated.

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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.