ClearanceBrief
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)
Get daily alerts for LDDSample briefCSV

Top companies in LDD

DateFirm and productCodeLinked 510(k)
Nov 26, 2024Remote 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
LDDK200849
Oct 22, 2024Physio-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
LDDK182503
Jun 6, 2024Remote Diagnostic Technologies Ltd.
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual
Open, Classified
LDDK200849
Jun 12, 2023Remote Diagnostic Technologies Ltd.
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
Open, Classified
LDDK200849
Jan 28, 2022Remote Diagnostic Technologies Ltd.
Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
Terminated
LDDNone listed
Dec 11, 2020Remote 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
LDDK200849
Dec 4, 2014ConMed 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
LDDK964469
Dec 4, 2014ConMed 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
LDDK964469
Jul 8, 2013Cardio 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
LDDK103159
Jan 12, 2012ConMed 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
LDDK964469
Nov 16, 2011Physio 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
LDDK012274
Aug 28, 2010Physio Control, Inc.
Pediatric Paddles attachments used with LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12 and LIFEPAK 20/20e Defibrillator/Monitors.
Terminated
LDDK902288
Aug 28, 2010Physio Control, Inc.
External Sterilizable Paddles for use with the LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12, and LIFEPAK 20/20e Defibrillator/Monitor.
Terminated
LDDK902288
Apr 7, 2009Physio Control, Inc.
Internal Sterilizable Paddles (electrodes) and Handles without discharge control for use with LIFEPAK 9 and LIFEPAK 9P defibrillators/monitors.
Terminated
LDDK881153
Sep 16, 2008Physio 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
LDDK063119
Sep 16, 2008Physio 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
LDDK063119
Sep 16, 2008Physio 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
LDDK063510
Sep 16, 2008Physio Control, Inc.
Internal Defibrillation Electrodes: PN: 805355-10 thru 14 and 805355-020 thru -024.
Terminated
LDDNone listed
Sep 16, 2008Physio 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
LDDK895379
Sep 8, 2008Physio Control, Inc.
Keypad replacement for LIFEPAK20 or LIFEPAK20e. This product is an external defibrillator.
Terminated
LDDK063119
Sep 8, 2008Physio Control, Inc.
Physio-Control LIFEPAK 20e defibrillator/monitor. This product is an external defibrillator sold internationally only
Terminated
LDDK063119
Sep 8, 2008Physio Control, Inc.
Physio-Control LIFEPAK 20 defibrillator/monitor. This product is an external defibrillator sold internationally and domestically.
Terminated
LDDK063119
Dec 19, 2006Medtronic Emergency Response Systems, Inc.
LIFEPAK 20 automatic external defibrillator
Terminated
LDDK012274
Sep 13, 2006Medtronic Emergency Response Systems, Inc.
LIFEPAK 20 external defibrillator/monitor
Terminated
LDDK012274
Apr 4, 2006Medtronic Emergency Response Systems, Inc.
LIFEPAK 20 defibrillator/monitor
Terminated
LDDK012274
Nov 2, 2005Medtronic Emergency Response Systems, Inc.
standard (hard) paddles used with the LIFEPAK 12 defibrillator/monitor series.
Terminated
LDDK012274
Nov 2, 2005Medtronic Emergency Response Systems, Inc.
QUIK-COMBO pacing/defibrillation/ECG (therapy) cables used with the LIFEPAK 12 defibrillator/monitor series.
Terminated
LDDK012274
Jul 13, 2005Medtronic Emergency Response Systems, Inc.
LIFEPAK 20 defbrillator/monitor
Terminated
LDDK012274
May 12, 2005Laerdal 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
LDDNone listed
Jul 20, 2004Medtronic Physio Control Corp
DC Power Adapter for use with the LIFEPAK 12 defibrillator/monitor.
Terminated
LDDK012274
Jul 20, 2004Medtronic Physio Control Corp
LIFEPAK 12 defibrillator/monitor.
Terminated
LDDK012274

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.