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)
Top companies in MKJ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 19, 2014 | Philips 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 |
MKJ | K020715 K040904 |
| Mar 12, 2014 | Philips 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 |
MKJ | K051134 |
| Mar 7, 2014 | Philips Medical Systems, Inc. Philips HeartStart MRx Monitor/Defibrillator
Model numbers: M3535A, M3536A, M3536M,M3536M4,M3536M6,861288,861289,861464,861483,and 861491 Terminated |
MKJ | None listed |
| Feb 26, 2014 | Philips 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 |
MKJ | K051134 |
| Feb 26, 2014 | Philips 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 |
MKJ | K051134 |
| Feb 26, 2014 | Philips 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 |
MKJ | K051134 |
| Feb 26, 2014 | Philips 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 |
MKJ | K051134 |
| Feb 26, 2014 | Philips Medical Systems, Inc. Philips HeartStart MRx Monitor/Defibrillator used
Model numbers: M3535A, M3536A, M3536J, M3536M, M3536MC Terminated |
MKJ | K051134 |
| Feb 26, 2014 | Philips 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 |
MKJ | K110825 |
| Feb 25, 2014 | Philips 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 |
MKJ | K051134 |
| Dec 31, 2013 | Philips 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 |
MKJ | K051134 |
| Dec 27, 2013 | Philips 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 |
MKJ | K051134 |
| Dec 24, 2013 | Philips 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 |
MKJ | K051134 |
| Jul 24, 2013 | Philips 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 |
MKJ | K051134 |
| Jul 19, 2013 | Physio 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 |
MKJ | K052057 |
| May 13, 2013 | ConMed 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 |
MKJ | K014209 |
| Apr 29, 2013 | Philips 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 |
MKJ | K051134 |
| Apr 10, 2013 | Physio 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 |
MKJ | K011144 |
| Feb 21, 2013 | Philips 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 |
MKJ | K110825 |
| Jan 4, 2013 | Philips 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 |
MKJ | K020715 |
| Jan 4, 2013 | Philips 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 |
MKJ | K050004 |
| Oct 27, 2012 | Heartsine 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 |
MKJ | K041067 K052465 |
| Oct 4, 2012 | Philips 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 |
MKJ | K021453 |
| Sep 17, 2012 | ZOLL 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 |
MKJ | K112432 |
| Sep 10, 2012 | Philips 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 |
MKJ | K051134 |
| Jul 11, 2012 | Philips 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 |
MKJ | K051134 |
| Jun 27, 2012 | Philips 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 |
MKJ | K051134 |
| Feb 27, 2012 | Cardiac 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 |
MKJ | K031987 K102496 |
| Sep 19, 2011 | Cardiac 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 |
MKJ | K031987 K040438 +1 |
| Aug 3, 2011 | Cardiac 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 |
MKJ | K012197 K970741 +2 |
| Jul 26, 2011 | Physio 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 |
MKJ | K052057 |
| Jun 22, 2011 | Physio 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 |
MKJ | K973486 |
| May 25, 2011 | ZOLL 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 |
MKJ | K042007 |
| May 16, 2011 | Defibtech, 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 |
MKJ | K013896 K033896 |
| Mar 18, 2011 | Physio 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 |
MKJ | K012274 K073089 |
| Mar 8, 2011 | Philips 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 |
MKJ | K051134 |
| Mar 4, 2011 | Physio 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 |
MKJ | K010918 |
| Dec 10, 2010 | Cardiac 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 |
MKJ | K060934 |
| Nov 29, 2010 | Philips 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 |
MKJ | K003565 K013425 |
| Nov 29, 2010 | Philips 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 |
MKJ | K003565 K013425 |
| Nov 29, 2010 | Philips 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 |
MKJ | K003565 K013425 |
| Nov 29, 2010 | Philips 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 |
MKJ | K003565 K013425 |
| Nov 29, 2010 | Philips 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 |
MKJ | K003565 K013425 |
| Nov 29, 2010 | Philips 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 |
MKJ | K003565 K013425 |
| Nov 26, 2010 | Philips Medical Systems HeartStart FR2+ automated external defibrillator (AED) model: M3841: LAERDAL brand; text prompts only on screen (NO ECG); no configurable manual charge. Terminated |
MKJ | K003565 K003819 +3 |
| Nov 26, 2010 | Philips Medical Systems HeartStart FR2+ automated external defibrillator (AED) model:
M3861: PHILIPS brand; text prompts only on screen (NO ECG); no configurable manual charge. Terminated |
MKJ | K003565 K003819 +3 |
| Nov 26, 2010 | Philips Medical Systems HeartStart FR2+ automated external defibrillator (AED) model:
M3840: LAERDAL brand; configurable ECG on screen; configurable manual charge in advance mode. Terminated |
MKJ | K003565 K003819 +3 |
| Nov 26, 2010 | Philips Medical Systems HeartStart FR2+ automated external defibrillator (AED) Model M3860: Philips brand; configurable ECG on screen; configurable manual charge in advance mode. Terminated |
MKJ | K003565 K003819 +3 |
| Nov 22, 2010 | Philips Medical Systems Philips HeartStart FRx Defibrillator, Automated External Defibrillator (AED), catalog number 861304. Terminated |
MKJ | K050004 |
| Nov 8, 2010 | Philips 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 |
MKJ | K051137 |
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