Home › PMT CORPORATION › Depthalon
Depthalon
PMT CORPORATION · Model 2104-08-16-003-NS · UDI-DI 00650551144403
GZL
Prescription
10
510(k) clearances
227
Adverse events (3 deaths)
24
Recalls
24
Facilities
Description
Depthalon Electrode, Platinum, Non-sterile, 8 Macro Contacts, 16 Microwire contacts, 38.5mm recording length, Inline connector, 1 exit, 2 leads, 2 exits
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-09-19 | Ad-Tech Medical Instrument Corporation | Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional symbol was incorrectly p |
| 2024-09-19 | Ad-Tech Medical Instrument Corporation | Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional symbol was incorrectly p |
| 2024-09-19 | Ad-Tech Medical Instrument Corporation | Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional symbol was incorrectly p |
| 2021-12-09 | DIXI MEDICAL USA | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag |
| 2021-12-09 | DIXI MEDICAL USA | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag |
| 2021-12-09 | DIXI MEDICAL USA | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag |
| 2021-12-09 | DIXI MEDICAL USA | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag |
| 2021-12-09 | DIXI MEDICAL USA | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag |
| 2021-12-09 | DIXI MEDICAL USA | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag |
| 2021-12-09 | DIXI MEDICAL USA | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.