Home › Device types › DSA
Cable, Transducer And Electrode, Patient, (Including Connector)
FDA product code DSA · Class 2 · Cardiovascular
12,224
Registered devices
622
Adverse events
12
Recalls
105
510(k) clearances
Devices with this code
INTEGRAL PROCESS Cables & Leadwires — NISSHA MEDICAL TECHNOLOGIES SASUnimed — Unimed Medical Supplies, Inc.Unimed — Unimed Medical Supplies, Inc.Unimed — Unimed Medical Supplies, Inc.Unimed — Unimed Medical Supplies, Inc.FOGG SYSTEM COMPANY, INC. — Fogg System Company, Inc.SKIN TEMP PROBE (REUSABLE) — RPIUnimed — Unimed Medical Supplies, Inc.FOGG SYSTEM COMPANY, INC. — Fogg System Company, Inc.Unimed — Unimed Medical Supplies, Inc.Unimed — Unimed Medical Supplies, Inc.NA — Conmed CorporationFOGG SYSTEM COMPANY, INC. — Fogg System Company, Inc.Unimed — Unimed Medical Supplies, Inc.Unimed — Unimed Medical Supplies, Inc.Unimed — Unimed Medical Supplies, Inc.Unimed — Unimed Medical Supplies, Inc.Unimed — Unimed Medical Supplies, Inc.Unimed — Unimed Medical Supplies, Inc.Unimed — Unimed Medical Supplies, Inc.Unimed — Unimed Medical Supplies, Inc.Unimed — Unimed Medical Supplies, Inc.9Line — Rising Eagle Medical LLCFOGG SYSTEM COMPANY, INC. — Fogg System Company, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-01-21 | Physio-Control, Inc. | Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions |
| 2022-02-03 | Volcano Corp | Multi-Modality Touch Screen Modules (MM-TSM), used with integrated IVUS systems, may crack, or become damaged, which may affect their usability. They could beco |
| 2019-08-01 | GN Otometrics | The electrode lead connector has a protruding conductor beyond insulation of approximately 0.1 mm. |
| 2019-07-19 | Philips North America, LLC | The thickness of the connector to the trunk cable on affected limb lead sets may be greater than specified. which may prevent or impede the performance of I 2-L |
| 2019-05-10 | GE Healthcare, LLC | ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the pa |
| 2019-05-10 | GE Healthcare, LLC | ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the pa |
| 2019-05-10 | GE Healthcare, LLC | ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the pa |
| 2019-05-10 | GE Healthcare, LLC | ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the pa |
| 2019-05-10 | GE Healthcare, LLC | ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the pa |
| 2014-03-05 | Remington Medical Inc. | Remington Medical discovered an error on the FL-601-97 IFU; part number IFU-RM-0154. Specifically, the polarity for the black chuck in the picture is wrong. It |
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