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HANDLE

KLS-Martin L.P. · Model 07-005-20-07 · UDI-DI 00888118009876

GZX Prescription
10
510(k) clearances
67
Adverse events (1 deaths)
1
Recalls
137
Facilities

Description

DISSECTOR, PITTSBURGH

Recalls

DateFirmReason
2007-01-22Medtronic Xomed, Inc.A labeling discrepancy was internally identified for the surface electrode component of REF 8263210 AccuGuide EMG Injection Needle, 30G X 25MM. The outside box label correctly ind

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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.