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Panels › Cardiovascular › Product code MKJ · Class 3

Automated External Defibrillators (Non-Wearable)

Regulation 870.5310

0510(k)s in 12 months (228 all time)
4recalls in 12 months (338 all time)
257recalls that name a 510(k)
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Top companies in MKJ

DateFirm and productCodeLinked 510(k)
Mar 19, 2014Philips Medical Systems North America Inc.
Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). Product Usage: The models M5066A, M5067A, and M5068A are designed for use on a person in sudden cardiac arrest who
Terminated
MKJK020715
K040904
Mar 12, 2014Philips Medical Systems, Inc.
Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A with Q-CPR Meter Option B08 The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrill
Terminated
MKJK051134
Mar 7, 2014Philips Medical Systems, Inc.
Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A, M3536M,M3536M4,M3536M6,861288,861289,861464,861483,and 861491
Terminated
MKJNone listed
Feb 26, 2014Philips Medical Systems, Inc.
Philips HeartStart MRx Monitor/Defibrillator; Models: M3535A, M3536A, M3536J, M3536M, M3536M5, and M3536MC. Used for the termination of ventricular tachycardia and ventricular fibrillation.
Terminated
MKJK051134
Feb 26, 2014Philips Medical Systems, Inc.
Philips HeartStart XL, Defibrillator/Monitor Model number M4735A Product Usage: The M4735A HeartStart XL Defibrillator/Monitor is for use in the hospital by qualified medical personnel trained in t
Terminated
MKJK051134
Feb 26, 2014Philips Medical Systems, Inc.
M3536A HeartStart MRx with Wireless Link Upgrade (861289) The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified
Terminated
MKJK051134
Feb 26, 2014Philips Medical Systems, Inc.
HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries Revision J The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is f
Terminated
MKJK051134
Feb 26, 2014Philips Medical Systems, Inc.
Philips HeartStart MRx Monitor/Defibrillator used Model numbers: M3535A, M3536A, M3536J, M3536M, M3536MC
Terminated
MKJK051134
Feb 26, 2014Philips Medical Systems, Inc.
Philips HeartStart XL+ Defibrillator/Monitor Model: 861290 The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and quali
Terminated
MKJK110825
Feb 25, 2014Philips Medical Systems, Inc.
HeartStart MRx Monitor/Defibrillator; Model(s), Catalogue, or Code Number: M3535A, M3536A, M3536J, M3536MC The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricula
Terminated
MKJK051134
Dec 31, 2013Philips Medical Systems, Inc.
Philips HeartStart MRx Monitor/Defibrillator Models: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 The HeartStart MRx is for use for the termination of ventricular tachycardia an
Terminated
MKJK051134
Dec 27, 2013Philips Medical Systems, Inc.
Philips HeartStart MRx Monitor/Defibrillator Models: M3536A Options A20 - A27, HeartStart MRx ALS Monitor (Grey) The HeartStart MRx is for use for the termination of ventricular tachycardia and ventr
Terminated
MKJK051134
Dec 24, 2013Philips Medical Systems, Inc.
Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for u
Terminated
MKJK051134
Jul 24, 2013Philips Healthcare Inc.
Philips HeartStart MRx Monitor/Defibrillator, Model numbers M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 The device is for use by qualified medical personnel trained i
Terminated
MKJK051134
Jul 19, 2013Physio Control, Inc.
The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient's electrocardiographic (ECG)
Terminated
MKJK052057
May 13, 2013ConMed Corporation
PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 2001M-C. The PadPro(R) Adult Radiotransparent Multifunction Electrodes with Carbon Leadwires and Medtronic(R) Connector are
Terminated
MKJK014209
Apr 29, 2013Philips Healthcare Inc.
HeartStart MRx Monitor/Defribillator; Product Codes: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. The HeartStart MRx is for use for the termination of ventricular tachycardi
Terminated
MKJK051134
Apr 10, 2013Physio Control, Inc.
The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators. Product part's numbers: 3200731-xxx, 3202177-xxx, U3200731-xxx, and U3202177-006. Automated external defibrillators.
Terminated
MKJK011144
Feb 21, 2013Philips Healthcare Inc.
Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290 The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device a
Terminated
MKJK110825
Jan 4, 2013Philips Medical Systems North America Co. Phillips
Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121
Terminated
MKJK020715
Jan 4, 2013Philips Medical Systems North America Co. Phillips
Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305 The FRx Defibrillator is intended to trea
Terminated
MKJK050004
Oct 27, 2012Heartsine Technologies, Limited
HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106 Product Usage: Samaritan 300/300P PAD is indicated for
Terminated
MKJK041067
K052465
Oct 4, 2012Philips Healthcare Inc.
Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The Heart Start XL Defibrillator/Monitor is a fully featured, defibrillator intended for use by qualified medical
Terminated
MKJK021453
Sep 17, 2012ZOLL Medical Corporation
Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac
Terminated
MKJK112432
Sep 10, 2012Philips Healthcare Inc.
Philips HeartStart MRx monitor/defibrillators Models: M3535A and M3536A, M3536J, M3536M, M3536MC, M3536M1, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6 The Heartstart MRx is for use for the terminatio
Terminated
MKJK051134
Jul 11, 2012Philips Healthcare Inc.
Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for
Terminated
MKJK051134
Jun 27, 2012Philips Healthcare Inc.
Philips HeartStart MRx monitor/defibrillators Models: M3535A, M3536A, M3536M4, M3536M5, and M3536M6 Product Usage: The Heartstart MRx is for use for the termination of ventricular tachycardia and ven
Terminated
MKJK051134
Feb 27, 2012Cardiac Science Corporation
Powerheart G3 Automated External Defibrillators (Non-Wearable) and include the following models: Powerheart 9300A, 9300E, 9300P, 9390A, 9390E; CardioVive 92532, 92533; Nihon-Kohden 9200G, 9231; and GE
Terminated
MKJK031987
K102496
Sep 19, 2011Cardiac Science Corporation
Powerheart Automated External Defibrillator (AED), G3 is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Post-resuscit
Terminated
MKJK031987
K040438 +1
Aug 3, 2011Cardiac Science Corporation
Automated External Defibrillator (non-wearable). Model number 9200, 9200N, 9200DN, 9200RD, 9210N, 9210RD, and CardioVive 92530. The battery component is warranted for 5 years, and electrodes have a
Terminated
MKJK012197
K970741 +2
Jul 26, 2011Physio Control, Inc.
The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient's electrocardiographic (E
Terminated
MKJK052057
Jun 22, 2011Physio Control, Inc.
12-lead ECG Cable Assembly contains the following cable and attachments: Main Cable with Limb Leads: The main cable includes the proximal connector which attaches to the monitor and four incorporated
Terminated
MKJK973486
May 25, 2011ZOLL Medical Corporation
Zoll E Series BLS Defibrillator/Pacemaker/Monitor Software versions 7.10 and 7.11 The product is used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rh
Terminated
MKJK042007
May 16, 2011Defibtech, LLC
Defibtech Lifeline AED and ReviveR AED, Model: DDU-100 Series AEDs Software version 2.004 or earlier The product under correction is the DDU-100 AED. The AED is indicated for use on victims of su
Terminated
MKJK013896
K033896
Mar 18, 2011Physio Control, Inc.
The LIFEPAK 20 defibrillator/monitor and LIFEPAK 20e. Product part numbers: 3202487-xxx, 3202488-000, U3202487-000, 3202488-015, and U3202488-000. The LIFEPAK 20 defibrillator/monitor and LIFEPAK 20
Terminated
MKJK012274
K073089
Mar 8, 2011Philips Healthcare Inc.
Philips HeartStart MRx Defibrillator Monitor (M3535A/M3536A) with software (SW) versions F.01.00 or F.01.01 and with all of the following hardware options EtCO2, IP and Temp. Used for the termination
Terminated
MKJK051134
Mar 4, 2011Physio Control, Inc.
The LIFEPAK12 Defibrillator/Monitor. The LIFEPAK12 Defibrillator/Monitor can be used in AED mode, manual mode or advisory mode. In AED mode, the LIFEPAK 12 is intended for use by personnel who are aut
Terminated
MKJK010918
Dec 10, 2010Cardiac Science Corporation
GE Responder 2000 Defibrillator/Monitor, models 2025653, 2026109, and 2026114 that were manufactured between July 25, 2008 and October 2, 2009 by GE Healthcare.
Terminated
MKJK060934
Nov 29, 2010Philips Medical Systems
HeartStart FR2+ AED with Text Display, Model 989803148611. This product is G2005 Update in accordance with the American Heart Association 2005 Guidelines for Cardiopulmonary Resuscitation and Emerge
Terminated
MKJK003565
K013425
Nov 29, 2010Philips Medical Systems
HeartStart FR2+ AED with ECG Display, Model 989803148601. This product is G2005 Update according to the American Heart Association 2005 Guidelines for Cardiopulmonary Resuscitation and Emergency Car
Terminated
MKJK003565
K013425
Nov 29, 2010Philips Medical Systems
HeartStart FR2+ AED with Text Display (No ECG), Model 3841, Laerdal brand, no configurable manual charge. The label of the device states: "HEARTSTART...FR2+ Automated External Defibrillator...Manufac
Terminated
MKJK003565
K013425
Nov 29, 2010Philips Medical Systems
HeartStart FR2+ AED with ECG Display, Model 3840, Laerdal brand, configurable manual charge in advance mode. The label of the device states: "HEARTSTART...FR2+ Automated External Defibrillator...Manu
Terminated
MKJK003565
K013425
Nov 29, 2010Philips Medical Systems
HeartStart FR2+ AED with Text Display (No ECG), Model M3861, Philips brand, no configurable manual charge. The label of the device states: "HEARTSTART...FR2+ Automated External Defibrillator...Manufa
Terminated
MKJK003565
K013425
Nov 29, 2010Philips Medical Systems
HeartStart FR2+ AED with ECG Display, Model M3860, Philips brand, configurable manual charge in advance mode. The label of the device states: "HEARTSTART...FR2+ Automated External Defibrillator...Man
Terminated
MKJK003565
K013425
Nov 26, 2010Philips Medical Systems
HeartStart FR2+ automated external defibrillator (AED) model: M3841: LAERDAL brand; text prompts only on screen (NO ECG); no configurable manual charge.
Terminated
MKJK003565
K003819 +3
Nov 26, 2010Philips Medical Systems
HeartStart FR2+ automated external defibrillator (AED) model: M3861: PHILIPS brand; text prompts only on screen (NO ECG); no configurable manual charge.
Terminated
MKJK003565
K003819 +3
Nov 26, 2010Philips Medical Systems
HeartStart FR2+ automated external defibrillator (AED) model: M3840: LAERDAL brand; configurable ECG on screen; configurable manual charge in advance mode.
Terminated
MKJK003565
K003819 +3
Nov 26, 2010Philips Medical Systems
HeartStart FR2+ automated external defibrillator (AED) Model M3860: Philips brand; configurable ECG on screen; configurable manual charge in advance mode.
Terminated
MKJK003565
K003819 +3
Nov 22, 2010Philips Medical Systems
Philips HeartStart FRx Defibrillator, Automated External Defibrillator (AED), catalog number 861304.
Terminated
MKJK050004
Nov 8, 2010Philips Healthcare Inc.
HeartStart MRx Defibrillator/Monitor Models: M3535A / M3536A / M3536J / M3536MC The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is
Terminated
MKJK051137

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