Home › Device types › LDD
Dc-Defibrillator, Low-Energy, (Including Paddles)
FDA product code LDD · Class 2 · Cardiovascular
1,054
Registered devices
16,579
Adverse events
31
Recalls
166
510(k) clearances
Devices with this code
Cardio Clear — CARDIO-MEDICAL PRODUCTS, INC.Unipower — UNIPOWER CORPORATIONUnipower — UNIPOWER CORPORATIONPEDIATRIC PADDLE ADAPTER — PHYSIO-CONTROL, INC.NA — FIAB SPAUnipower — UNIPOWER CORPORATIONUnipower — UNIPOWER CORPORATIONUnipower — UNIPOWER CORPORATIONUnipower — UNIPOWER CORPORATIONInternal Handle — Zoll Medical CorporationPediatric (infant), radiolucent, defib electrodes w/ Physio connector — HEART SYNC INCM SERIES BIPHASIC — Zoll Medical CorporationM SERIES BIPHASIC — Zoll Medical CorporationUnipower — UNIPOWER CORPORATIONUnipower — UNIPOWER CORPORATIONUnipower — UNIPOWER CORPORATIONR Series — Zoll Medical CorporationUnipower — UNIPOWER CORPORATIONHeartsync by Vermed — GRAPHIC CONTROLS ACQUISITION CORPUnipower — UNIPOWER CORPORATIONUnipower — UNIPOWER CORPORATIONM SERIES BIPHASIC — Zoll Medical CorporationTempus LS-MANUAL — Schiller AGUnipower — UNIPOWER CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-10-28 | Remote Diagnostic Technologies Ltd. | Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number. |
| 2024-08-09 | Physio-Control, Inc. | Due to customer complaints and out of box failures, the firm is conducting a voluntary recall as a result of product failures (cracks and over-molding separatio |
| 2024-05-09 | Remote Diagnostic Technologies Ltd. | Simultaneous ECG measurements with multiple devices, including a manual defibrillator, on the same patient may cause electrical noise or interference, which may |
| 2023-05-08 | Remote Diagnostic Technologies Ltd. | Defibrillator/pacemaker module (DPM) may encounter a problem causing communication from the Mainboard to the DPM to fail, leading to no or ineffective pacing wi |
| 2022-01-28 | Remote Diagnostic Technologies Ltd. | Distribution of Defibrillators that are not approved or cleared for distribution US Market. |
| 2020-11-17 | Remote Diagnostic Technologies Ltd. | A software error was detected within software version 1.3.4 for the Tempus LS device. When exiting pacer back into manual mode the pacer pulse wave may put the |
| 2014-11-06 | ConMed Corporation | Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure t |
| 2014-11-06 | ConMed Corporation | Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure t |
| 2013-04-26 | Cardio Medical Products | Covidien received customer reports of Arcing/Sparking on the defibrillation electrode leadwire which may affect Cardio Medical Products Inc. defibrillator elect |
| 2011-03-09 | ConMed Corporation | The product lot was assembled with an R2 Connector, rather than a Zoll Connector. |
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