510(k) K012218 ยท DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES
| Applicant | The Ludlow Company LP, Chicopee MA, US |
| Decision | Substantially Equivalent, Oct 12, 2001 |
| Received | Jul 16, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012218
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 2, 2015 | Covidien LLC MediTrace Cadence Adult Multi-Function Defibrillation Electrodes
Item Code:22550PC Terminated |
DRO | None listed |
| Sep 2, 2015 | Covidien LLC MediTrace Cadence Adult Zoll, Preconnect
Defibrillation Electrode, Nonsterile
Item Code:22770PC Terminated |
DRO | None listed |
| Oct 15, 2014 | Covidien LLC Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes, Radiotransparent
Part Number: 22660R Terminated |
DRO | None listed |
| Oct 15, 2014 | Covidien LLC Coviden Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pre-connected
Part Number: 22660PC Terminated |
DRO | None listed |
| Oct 15, 2014 | Covidien LLC Covidien Kendall Adult Multi-Function Defibrillation Electrodes
Part Number: 20660 Terminated |
DRO | None listed |
| Oct 15, 2014 | Covidien LLC Philips HEARTSTART Multifunction Electrode Pads
Part Number: M3718A Terminated |
DRO | None listed |
| Apr 29, 2013 | Covidien LLC Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode
Product ID: 22550R.
Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures. Terminated |
DRO | None listed |
| Apr 29, 2013 | Covidien LLC Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode
Product ID: 22550P.
Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures. Terminated |
DRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.