FDA Device Intelligence
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Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)

FDA product code DRO · Class 2 · Cardiovascular

497
Registered devices
599
Adverse events
22
Recalls
84
510(k) clearances

Devices with this code

M SERIES BIPHASIC — Zoll Medical CorporationM SERIES BIPHASIC — Zoll Medical CorporationM SERIES BIPHASIC — Zoll Medical CorporationM SERIES BIPHASIC — Zoll Medical CorporationM SERIES BIPHASIC — Zoll Medical CorporationM SERIES BIPHASIC — Zoll Medical CorporationDefibrillation Electrodes — Tz Medical, Inc.M SERIES BIPHASIC — Zoll Medical CorporationDefibrillation Electrodes — Tz Medical, Inc.R Series — Zoll Medical CorporationR SERIES — Zoll Medical CorporationDefibrillation Electrodes — Tz Medical, Inc.M SERIES BIPHASIC — Zoll Medical CorporationM SERIES BIPHASIC — Zoll Medical CorporationM SERIES BIPHASIC — Zoll Medical CorporationDefibrillation Electrodes — Tz Medical, Inc.M SERIES BIPHASIC — Zoll Medical CorporationTempus LS-MANUAL — Schiller AGM SERIES BIPHASIC — Zoll Medical CorporationM SERIES BIPHASIC — Zoll Medical CorporationM SERIES BIPHASIC — Zoll Medical CorporationM SERIES BIPHASIC — Zoll Medical CorporationM SERIES BIPHASIC — Zoll Medical CorporationM SERIES BIPHASIC — Zoll Medical Corporation

Recent recalls

DateFirmReason
2020-03-10Smiths Medical ASD Inc.Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
2020-03-10Smiths Medical ASD Inc.Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
2020-03-10Smiths Medical ASD Inc.Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
2020-03-10Smiths Medical ASD Inc.Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
2020-03-10Smiths Medical ASD Inc.Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
2020-03-10Smiths Medical ASD Inc.Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
2020-03-10Smiths Medical ASD Inc.Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
2020-03-10Smiths Medical ASD Inc.Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
2020-03-10Smiths Medical ASD Inc.Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
2020-03-10Smiths Medical ASD Inc.Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.