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Matrix Wearable

GLOBAL INSTRUMENTATION, LLC · Model 009-400-0193 · UDI-DI 00815187020587

DSH Prescription
1
510(k) clearances
962
Adverse events (6 deaths)
0
Recalls
57
Facilities

Description

M5 Recorder, 2-Lead Patient Cable AHA, System Kit 00815187020556; M5 Recorder 00815187020440; M5 2-Lead Patient Cable AHA 00815187020549; M5 USB Cable 1-Meter

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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.