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E1 electrode set (7 tips)
BONART CO., LTD. · Model 73120185 · UDI-DI 04719873120185
1
510(k) clearances
13
Adverse events
1
Recalls
9
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2006-04-05 | Macan 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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Get your free API keyRead the docsData 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.