This company has registrations in United States, Canada, Australia — 3 overseas markets. The China NMPA lookup is still pending.
Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.
Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K150198 | CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel | 2015-05-02 |
| US | K150055 | OneStep Pediatric CPR Multi-Function Electrode | 2015-05-02 |
| US | K133441 | ONESTEP CPR II MULTI-FUNCTION ELECTRODE | 2014-10-10 |
| CA | 71367 | ECG ELECTRODES | Class II |
| CA | 71368 | COMMODITY STYLE ELECTRODES | Class II |
| CA | 87536 | BIO-DETEK ADULT ELECTRODES FOR USE WITH MEDTRONIC LIFEPAK DEFIBRILLATORS | Class II |