1 device · 1 company · 2012
Product code OEE: Diagnostic Low Electric Field
1 device under product code OEE, 2012, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Diagnostic Low Electric Field. As an adjunctive tool to guide the shavings of tissue at the margins of the tumor for use in excisional breast surgery to assist in locating the tissue for excision. In addition to other standard methods such as intraoperative imaging and palpation. MAUDE held 1 adverse-event report against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| DUNE MEDICAL DEVICES MARGINPROBE SYSTEMP110014 · PMA | Dilon Medical Technologies, Ltd. | General and Plastic Surgery | database entry |
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