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Intravascular Bleed Monitor

FDA product code QFJ · Class 2 · Cardiovascular

2
Registered devices
3
Adverse events
1
Recalls
2
510(k) clearances

Devices with this code

Early Bird Bleed Monitoring System — SARANAS INC.Early Bird Bleed Monitoring System — SARANAS INC.

Recent recalls

DateFirmReason
2022-08-10Saranas, Inc.Bleed monitoring system device design error, causing the device to not power on and complete the series of self-tests so instructions for use being updated to i

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.