ClearanceBrief
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)
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Top companies in DRO

DateFirm and productCodeLinked 510(k)
Mar 10, 2020Smiths Medical ASD Inc.
smiths medical medex CBSS-5ML, Double set, (172+15cm), Model Number DPSHC0094
Terminated
DRONone listed
Mar 10, 2020Smiths Medical ASD Inc.
smiths medical medex CBSS-5ML, Single Set, (172/15cm), Model Number DPSHC0093
Terminated
DRONone listed
Mar 10, 2020Smiths Medical ASD Inc.
smiths medical medex CBSS-5ML, Triple set, (172/15cm), Model Number DPSHC0092
Terminated
DRONone listed
Mar 10, 2020Smiths Medical ASD Inc.
smiths medical medex CBSS-5ML Antishunt set, (172/15cm), Model Number DPSHC0091
Terminated
DRONone listed
Mar 10, 2020Smiths Medical ASD Inc.
smiths medical medex CBSS-5ML Zweifach set, Model Number DPSHC0090
Terminated
DRONone listed
Mar 10, 2020Smiths Medical ASD Inc.
smiths medical medex CBSS 5 ml, zweifach proximaler Entnahmeport 60 cm, Model Number DPSHC0084
Terminated
DRONone listed
Mar 10, 2020Smiths Medical ASD Inc.
smiths medical medex CBSS 5 ml, einfach proximaler Entnahmeport 60 cm, Model Number DPSHC0083
Terminated
DRONone listed
Mar 10, 2020Smiths Medical ASD Inc.
smiths medical medex CBSS 5 ml, dreifach proximaler Entnahmeport 60 cm, Model number DPSHC0082
Terminated
DRONone listed
Mar 10, 2020Smiths Medical ASD Inc.
smiths medical medex CBSS 5 ml, Antishunt proximaler Entnahmeport 60 cm, Model Number DPSHC0081
Terminated
DRONone listed
Mar 10, 2020Smiths Medical ASD Inc.
smiths medical medex CBSS 2-fach Druckmesset mit Option, Model Number DPSHC0076
Terminated
DRONone listed
Mar 10, 2020Smiths 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
DRONone listed
Mar 10, 2020Smiths Medical ASD Inc.
medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181P1 e) MX96AE211P1
Terminated
DRONone listed
Sep 2, 2015Covidien LLC
MediTrace Cadence Adult Zoll, Preconnect Defibrillation Electrode, Nonsterile Item Code:22770PC
Terminated
DROK012218
Sep 2, 2015Covidien LLC
MediTrace Cadence Adult Multi-Function Defibrillation Electrodes Item Code:22550PC
Terminated
DROK012218
Oct 15, 2014Covidien LLC
Philips HEARTSTART Multifunction Electrode Pads Part Number: M3718A
Terminated
DROK012218
Oct 15, 2014Covidien LLC
Covidien Kendall Adult Multi-Function Defibrillation Electrodes Part Number: 20660
Terminated
DROK012218
Oct 15, 2014Covidien LLC
Coviden Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pre-connected Part Number: 22660PC
Terminated
DROK012218
Oct 15, 2014Covidien LLC
Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes, Radiotransparent Part Number: 22660R
Terminated
DROK012218
May 30, 2013TZ 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
DROK983196
Apr 29, 2013Covidien LLC
Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product ID: 22550P. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.
Terminated
DROK012218
Apr 29, 2013Covidien LLC
Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product ID: 22550R. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.
Terminated
DROK012218
Jan 24, 2011Welch Allyn Protocol, Inc
Welch Allyn PIC 50 Portable Intensive Care System. Model 971081 series. Designed for use in and out of the hospital.
Terminated
DROK974034

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