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Parkell®

PARKELL, INC. · Model P-04 · UDI-DI 00810000526727

EKZ Prescription
10
510(k) clearances
13
Adverse events
1
Recalls
9
Facilities

Description

P4 Proximal Hemostasis Electrosurge Electrode

Recalls

DateFirmReason
2006-04-05Macan Engineering and Manufacturing Co., Inc.The product label fails to warn users to use the device on patients with shielded pacemakers only.

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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.