Panels › Cardiovascular › Product code DRO · Class 2
Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Regulation 870.5550
0510(k)s in 12 months (84 all time)
0recalls in 12 months (22 all time)
10recalls that name a 510(k)
Top companies in DRO
| Company | 510(k)s | Recalls |
|---|---|---|
| Cardiac Resucitator Corp. | 13 | 0 |
| Smiths Medical ASD Inc. | 0 | 12 |
| Physio-Control Corp. | 10 | 0 |
| Cardiotronics, Inc. | 9 | 0 |
| Covidien LLC | 0 | 8 |
| Medac, Inc. | 8 | 0 |
| Katecho, Inc. | 4 | 0 |
| Zmi Corp. | 4 | 0 |
| Medical Data Electronics | 3 | 0 |
| Tz Medical, Inc. | 2 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 10, 2020 | Smiths Medical ASD Inc. smiths medical medex CBSS-5ML, Double set, (172+15cm), Model Number DPSHC0094 Terminated |
DRO | None listed |
| Mar 10, 2020 | Smiths Medical ASD Inc. smiths medical medex CBSS-5ML, Single Set, (172/15cm), Model Number DPSHC0093 Terminated |
DRO | None listed |
| Mar 10, 2020 | Smiths Medical ASD Inc. smiths medical medex CBSS-5ML, Triple set, (172/15cm), Model Number DPSHC0092 Terminated |
DRO | None listed |
| Mar 10, 2020 | Smiths Medical ASD Inc. smiths medical medex CBSS-5ML Antishunt set, (172/15cm), Model Number DPSHC0091 Terminated |
DRO | None listed |
| Mar 10, 2020 | Smiths Medical ASD Inc. smiths medical medex CBSS-5ML Zweifach set, Model Number DPSHC0090 Terminated |
DRO | None listed |
| Mar 10, 2020 | Smiths Medical ASD Inc. smiths medical medex CBSS 5 ml, zweifach proximaler Entnahmeport 60 cm, Model Number DPSHC0084 Terminated |
DRO | None listed |
| Mar 10, 2020 | Smiths Medical ASD Inc. smiths medical medex CBSS 5 ml, einfach proximaler Entnahmeport 60 cm, Model Number DPSHC0083 Terminated |
DRO | None listed |
| Mar 10, 2020 | Smiths Medical ASD Inc. smiths medical medex CBSS 5 ml, dreifach proximaler Entnahmeport 60 cm, Model number DPSHC0082 Terminated |
DRO | None listed |
| Mar 10, 2020 | Smiths Medical ASD Inc. smiths medical medex CBSS 5 ml, Antishunt proximaler Entnahmeport 60 cm, Model Number DPSHC0081 Terminated |
DRO | None listed |
| Mar 10, 2020 | Smiths Medical ASD Inc. smiths medical medex CBSS 2-fach Druckmesset mit Option, Model Number DPSHC0076 Terminated |
DRO | None listed |
| Mar 10, 2020 | Smiths Medical ASD Inc. smiths medical medex HemoDraw Plus Closed Blood Sampling Set with LogiCal Pressure Monitoring System, Model Numbers:
a) MX961H182P1
b) MX961H212P1
c) MX962H182P1
d) MX962H212P1 Terminated |
DRO | None listed |
| Mar 10, 2020 | Smiths Medical ASD Inc. medex LogiCal 5mL Closed Blood Sampling System, Model Numbers:
a) MX961E181P1
b) MX961E211P1
c) MX962E211P1
d) MX96AE181P1
e) MX96AE211P1 Terminated |
DRO | None listed |
| Sep 2, 2015 | Covidien LLC MediTrace Cadence Adult Zoll, Preconnect
Defibrillation Electrode, Nonsterile
Item Code:22770PC Terminated |
DRO | K012218 |
| Sep 2, 2015 | Covidien LLC MediTrace Cadence Adult Multi-Function Defibrillation Electrodes
Item Code:22550PC Terminated |
DRO | K012218 |
| Oct 15, 2014 | Covidien LLC Philips HEARTSTART Multifunction Electrode Pads
Part Number: M3718A Terminated |
DRO | K012218 |
| Oct 15, 2014 | Covidien LLC Covidien Kendall Adult Multi-Function Defibrillation Electrodes
Part Number: 20660 Terminated |
DRO | K012218 |
| Oct 15, 2014 | Covidien LLC Coviden Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pre-connected
Part Number: 22660PC Terminated |
DRO | K012218 |
| Oct 15, 2014 | Covidien LLC Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes, Radiotransparent
Part Number: 22660R Terminated |
DRO | K012218 |
| May 30, 2013 | TZ Medical Inc. adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model P-211-M1 and P-214-M1.
Product Usage:
Used by trained professionals in hospitals, doctors offices, and Emergency M Terminated |
DRO | K983196 |
| 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 | K012218 |
| 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 | K012218 |
| Jan 24, 2011 | Welch Allyn Protocol, Inc Welch Allyn PIC 50 Portable Intensive Care System. Model 971081 series.
Designed for use in and out of the hospital. Terminated |
DRO | K974034 |
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