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Cadwell
Technomed Engineering B.V. · Model 302881-000 · UDI-DI 08720791375911
10
510(k) clearances
150
Adverse events
2
Recalls
39
Facilities
Description
The kit consists of: • 1x Ground Electrode 40x50mm (302299-000-078), • 2x Twisted Pair Surface Electrode 20x25mm disk (302880-000), • White Subdermal Needle (302864-000), and • 8x Twisted Subdermal Needles (white or black+ red, blue, purple, orange) (302868-000).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-08-09 | Technomed Europe | Burns of varying degrees can occur to patients with electrodes left in while in the MRI scanner as a result of inadequate safety information in the IFU. |
| 2007-04-12 | Chalgren Enterprises Inc | Sterility Compromised-- Investigation found that individual packaging seals were separating, which may compromise sterility. |
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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.