Panels › Cardiovascular › Product code LDD · Class 2
Dc-Defibrillator, Low-Energy, (Including Paddles)
Regulation 870.5300
0510(k)s in 12 months (166 all time)
0recalls in 12 months (31 all time)
28recalls that name a 510(k)
Top companies in LDD
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 26, 2024 | Remote Diagnostic Technologies Ltd. Tempus LS-Manual Defibrillator Model 00-3020
The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode Open, Classified |
LDD | K200849 |
| Oct 22, 2024 | Physio-Control, Inc. STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20
STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15
Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, s Open, Classified |
LDD | K182503 |
| Jun 6, 2024 | Remote Diagnostic Technologies Ltd. Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual Open, Classified |
LDD | K200849 |
| Jun 12, 2023 | Remote Diagnostic Technologies Ltd. Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 Open, Classified |
LDD | K200849 |
| Jan 28, 2022 | Remote Diagnostic Technologies Ltd. Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693 Terminated |
LDD | None listed |
| Dec 11, 2020 | Remote Diagnostic Technologies Ltd. Tempus LS - Manual Defibrillator, Model Number: 00-3020
Software Version: 1.3.4 - Product Usage: The device is intended to be used in the following environmental: - Primarily in pre-hospital care and Terminated |
LDD | K200849 |
| Dec 4, 2014 | ConMed Corporation CONMED ADULT R2 Multifunction Electrodes, REF/Catalog Number 3115-1751, Direct Connect to Philips Heartstart, Rx ONLY --- ASSEMBLED IN MEXICO -Intended for use during defibrillation, cardioversion, pa Terminated |
LDD | K964469 |
| Dec 4, 2014 | ConMed Corporation CONMED PEDIATRIC R2 Multifunction Electrodes, REF/Catalog Number 3115-1750, Direct Connect to Philips Heartstart, Rx ONLY --- ASSEMBLED IN MEXICO -Intended for use during defibrillation, cardioversion Terminated |
LDD | K964469 |
| Jul 8, 2013 | Cardio Medical Products Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only
Manufactured for Cardio Medical Products 385 Franklin Avenue, Sui Terminated |
LDD | K103159 |
| Jan 12, 2012 | ConMed Corporation R2 Adult Zoll Non-Radiolucent Multifunction Electrodes, Catalog/REF 3111-1721, NON-STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13505.
This device, when connected to a Terminated |
LDD | K964469 |
| Nov 16, 2011 | Physio Control, Inc. The LIFEPAK 20 defibrillator/monitor is an AC powered external defibrillator with battery backup used by healthcare providers in hospital and clinic settings.
Affected Product Part Numbers: 3202487- Terminated |
LDD | K012274 |
| Aug 28, 2010 | Physio Control, Inc. Pediatric Paddles attachments used with LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12 and LIFEPAK 20/20e Defibrillator/Monitors. Terminated |
LDD | K902288 |
| Aug 28, 2010 | Physio Control, Inc. External Sterilizable Paddles for use with the LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12, and LIFEPAK 20/20e Defibrillator/Monitor. Terminated |
LDD | K902288 |
| Apr 7, 2009 | Physio Control, Inc. Internal Sterilizable Paddles (electrodes) and Handles without discharge control for use with LIFEPAK 9 and LIFEPAK 9P defibrillators/monitors. Terminated |
LDD | K881153 |
| Sep 16, 2008 | Physio Control, Inc. Physio-Control LIFEPAK 20e defibrillator/monitor, sold internationally only, is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomati Terminated |
LDD | K063119 |
| Sep 16, 2008 | Physio Control, Inc. Physio-Control LIFEPAK 20 defibrillator/monitor is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Terminated |
LDD | K063119 |
| Sep 16, 2008 | Physio Control, Inc. Physio-Control LIFEPAK 12 defibrillator/monitor is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Terminated |
LDD | K063510 |
| Sep 16, 2008 | Physio Control, Inc. Internal Defibrillation Electrodes: PN: 805355-10 thru 14 and 805355-020 thru -024. Terminated |
LDD | None listed |
| Sep 16, 2008 | Physio Control, Inc. Physio-Control Internal Defibrillator Handles. PN: 3010901-002 for use with LIFEPAK 12 and 20. PN: 805249-014 thru 019 for use with LIFEPAK 9 and 9P. Terminated |
LDD | K895379 |
| Sep 8, 2008 | Physio Control, Inc. Keypad replacement for LIFEPAK20 or LIFEPAK20e. This product is an external defibrillator. Terminated |
LDD | K063119 |
| Sep 8, 2008 | Physio Control, Inc. Physio-Control LIFEPAK 20e defibrillator/monitor. This product is an external defibrillator sold internationally only Terminated |
LDD | K063119 |
| Sep 8, 2008 | Physio Control, Inc. Physio-Control LIFEPAK 20 defibrillator/monitor. This product is an external defibrillator sold internationally and domestically. Terminated |
LDD | K063119 |
| Dec 19, 2006 | Medtronic Emergency Response Systems, Inc. LIFEPAK 20 automatic external defibrillator Terminated |
LDD | K012274 |
| Sep 13, 2006 | Medtronic Emergency Response Systems, Inc. LIFEPAK 20 external defibrillator/monitor Terminated |
LDD | K012274 |
| Apr 4, 2006 | Medtronic Emergency Response Systems, Inc. LIFEPAK 20 defibrillator/monitor Terminated |
LDD | K012274 |
| Nov 2, 2005 | Medtronic Emergency Response Systems, Inc. standard (hard) paddles used with the LIFEPAK 12 defibrillator/monitor series. Terminated |
LDD | K012274 |
| Nov 2, 2005 | Medtronic Emergency Response Systems, Inc. QUIK-COMBO pacing/defibrillation/ECG (therapy) cables used with the LIFEPAK 12 defibrillator/monitor series. Terminated |
LDD | K012274 |
| Jul 13, 2005 | Medtronic Emergency Response Systems, Inc. LIFEPAK 20 defbrillator/monitor Terminated |
LDD | K012274 |
| May 12, 2005 | Laerdal Medical Corporation LAERDAL ADAPTER CABLE, Cat. No. 920650. The cables allow the use of the Laerdal HeartStart multifunction defibrillator pads to be used with the HeartStart 3000 and 4000 series defibrillators and Phil Terminated |
LDD | None listed |
| Jul 20, 2004 | Medtronic Physio Control Corp DC Power Adapter for use with the LIFEPAK 12 defibrillator/monitor. Terminated |
LDD | K012274 |
| Jul 20, 2004 | Medtronic Physio Control Corp LIFEPAK 12 defibrillator/monitor. Terminated |
LDD | K012274 |
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