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DOMICO MED-DEVICE, LLC · Model 21577 · UDI-DI 00810050242585

IWYFMQ
10
510(k) clearances
17
Adverse events (2 deaths)
1
Recalls
28
Facilities

Description

PAD, FOREHEAD, .50 X 2.00 X 6.00

Recalls

DateFirmReason
2007-06-05Brainlab AGTarget Alignment Error : A mechanical component/software incompatibility caused by a specific combination of the BrainLAB Target Positioner version 40700-3A for Leksell headrings a

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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.