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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)
Aug 4, 2017ZOLL Medical Corporation
OneStep CPR Complete, Adult Multi Function Electrodes, Part Numbers: 8900 0214 01 (case of 8 single electrodes, UDI: 10847946016279) and 8900 0224 01 (single electrode, UDI: 00847946016272) Product U
Terminated
MKJK110742
Jul 17, 2017Philips Electronics North America Corporation
ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync cables All units of Philips sync cables model M1783A and M5526A as well as Philips ECG out cables model 989803195641. Manufactured - Septembe
Terminated
MKJK031187
K040404 +3
Mar 24, 2017Philips North America, LLC
HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9
Terminated
MKJK031187
K040404 +3
Mar 3, 2017Physio-Control, Inc.
The LIFEPAK 1000 defibrillator is intended for use by personnel who are authorized by a physician/medical director and are trained in CPR and the use of the LIFEPAK 1000 defibrillator.
Terminated
MKJK122600
Feb 11, 2017Physio-Control, Inc.
LIFEPAK 15 Monitor, Automated External Defibrillator (AED), Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is
Terminated
MKJK142430
Jan 16, 2017Physio-Control, Inc.
LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option. Intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions sp
Terminated
MKJK142430
Jan 16, 2017Physio-Control, Inc.
LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. The device is used in various areas of the hospital such as critical areas (emergency departments, critical care, operating room, etc.) an
Terminated
MKJK102972
Oct 14, 2016Leonhard Lang Medizintechnik GmbH
Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use
Terminated
MKJK142803
Aug 26, 2016Philips Electronics North America Corporation
HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A
Terminated
MKJK031187
K040404 +3
Jun 15, 2016Physio-Control, Inc.
LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed. Part numbers: V15-2-xxxxxx (includes software version 1 and version 2); V15-5-xxxxxx (inclues software version 4). The
Terminated
MKJK142430
May 25, 2016Physio-Control, Inc.
LIFEPAK CR Plus and/or LIFEPAK EXPRESS are Automatic External Defibrillator(s) and are non-wearable. LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators are intended for use on patients in cardiac arr
Terminated
MKJK033275
Apr 14, 2016Philips Electronics North America Corporation
HeartStart MRx Monitor/Defibrillator The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel tra
Terminated
MKJK031187
K040404 +4
Mar 9, 2016Cardiac Science Corporation
9131-001 Defibrillation Electrodes, Lot No. 141125-02 Used in Powerheart G3 9300A, 9300E, 9300P, 9390A, and 9390E AEDs Cardiac Science 9131 Defibrillation Electrodes are single use and intended to be
Terminated
MKJK102496
Nov 20, 2015Philips Electronics North America Corporation
Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. For use for the termination of ventricular tachycardia and ventricular fibr
Terminated
MKJK031187
K040404 +3
Nov 13, 2015Philips Electronics North America Corporation
ECG Out Cable,for use with a Philips ALS monitor/ defibrillator and bedside monitor for Synchronized cardioversion and Transcutaneous pacing. M1783A/M5526A 12-pin Sync cables, used with HeartStart
Terminated
MKJK031187
K040404 +2
Nov 10, 2015Philips Medical Systems, Inc.
Philips HeartStart MRx Monitor/Defibrillator Models:M3535A, M3536A, M3536M, M3536MC, M3536M4, M3536M5 The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibri
Terminated
MKJK031187
K040404 +3
Nov 5, 2015Philips Medical Systems, Inc.
HeartStart MRx monitor/defibrillator Models M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Product Usage: The HeartStart MRx is for use for the termination of ventricular
Terminated
MKJK031187
K040404 +4
Nov 3, 2015Philips Medical Systems, Inc.
Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A
Terminated
MKJK031187
K040404 +4
Sep 2, 2015Covidien LLC
Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak Preconnect System Item Code:PM20022
Terminated
MKJK960329
Aug 4, 2015Philips Electronics North America Corporation
Philips HeartStart XL+ Defibrillator/Monitor Product Usage: The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qual
Terminated
MKJK110825
Jan 13, 2015Philips Medical Systems, Inc.
HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Product Usage: The HeartStart MRx is for use for the termination of v
Terminated
MKJK031187
K040404 +4
Dec 24, 2014Heart Sync, Inc.
ADULT/CHILD Radiotranslucent Electrode, Part number T100AC-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended fo
Terminated
MKJK080421
Dec 24, 2014Heart Sync, Inc.
ADULT Radiotranslucent Electrode, Part number T100-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use du
Terminated
MKJK080421
Dec 24, 2014Heart Sync, Inc.
ADULT Radiotranslucent Electrode, Part number T100LO-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use
Terminated
MKJK080421
Dec 24, 2014Heart Sync, Inc.
ADULT/CHILD Radiotransparent Electrode, Part number C100AC-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended f
Terminated
MKJK080421
Dec 24, 2014Heart Sync, Inc.
ADULT Radiotransparent Electrode, Part number C100-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use d
Terminated
MKJK080421
Dec 19, 2014Leonhard Lang Gmbh
GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF 2059144-001 and 2059144-005. . Product Usage: Usage: Skintact Pediatric Multifunction Electrodes are for use o
Terminated
MKJK081371
Dec 4, 2014ConMed Corporation
MINI PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2602H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR--Intended for use during defibrillation, cardi
Terminated
MKJK002280
Dec 4, 2014ConMed Corporation
PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2603H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
Terminated
MKJK020288
Dec 4, 2014ConMed Corporation
ADULT Radiotransparent Electrode, REF/Catalog Number 2516H-PC, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
Terminated
MKJK020203
Dec 4, 2014ConMed Corporation
ADULT Radiotransparent Electrode, REF/Catalog Number 2516H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
Terminated
MKJK020203
Dec 4, 2014ConMed Corporation
ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-PC, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
Terminated
MKJK014209
Dec 4, 2014ConMed Corporation
ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-C, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
Terminated
MKJK014209
Dec 4, 2014ConMed Corporation
ADULT Radiotransparent Electrode, REF/Catalog Number 2001H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR Intended for use during defibrillation, cardioversion,
Terminated
MKJK014209
Oct 15, 2014Covidien LLC
MediChoice Multifunction Electrode Part Number: MC171 OH
Terminated
MKJK955882
Oct 15, 2014Covidien LLC
Covidien Kendall 1710H Multi-Function Defibrillation Electrodes Part Number: 40000006
Terminated
MKJK955882
Oct 9, 2014Bio-Detek, Inc.
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, 1 single Part number: 8900-4055-40 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillat
Terminated
MKJK943698
Oct 9, 2014Bio-Detek, Inc.
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900-4052 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult
Terminated
MKJK943698
Oct 9, 2014Bio-Detek, Inc.
ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single. Part number: 8900-4013 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disp
Terminated
MKJK943698
Oct 9, 2014Bio-Detek, Inc.
ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable
Terminated
MKJK943698
Sep 17, 2014Bio-Detek, Inc.
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900-4052 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These d
Terminated
MKJK943698
Sep 17, 2014Bio-Detek, Inc.
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) Part number: 8900-4013 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable sing
Terminated
MKJK943698
Sep 17, 2014Bio-Detek, Inc.
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes Part number: 8900-4012 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's
Terminated
MKJK943698
Sep 2, 2014Bio-Detek, Inc.
Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak Defibrillators, models 9, 10C, 11, 12, 15, 20, 500 and are indicated for Defibrillation, Cardioversion, Pacing, and Monit
Terminated
MKJK033771
Jul 24, 2014Heartsine Technologies, Limited
Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P). Automated External Defibrillator electrode supplies. The Pedi-Pak is specifically design
Terminated
MKJK052465
K123881
May 23, 2014Physio-Control, Inc.
LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX The LP1000 (in AED mode) is indicated for use on patients in cardiac arrest.
Terminated
MKJK042404
Apr 9, 2014Philips Medical Systems, Inc.
Philips HeartStart XL+ Defibrillator/Monitor with system software version B.00.00 or B.00.01 installed Model: 861290, automatic external defibrillator.
Terminated
MKJK110825
Apr 9, 2014Philips Medical Systems, Inc.
Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290, automatic external defibrillator.
Terminated
MKJK110825
Mar 31, 2014ZOLL Medical Corporation
Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Version 02.10.02.00 or Higher, automated external defibrillator.
Terminated
MKJK112432
K112761 +1
Mar 19, 2014Philips Medical Systems North America Inc.
Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 and 861389. The HeartStart FR3 is a battery powered automated external defibrillator (AED) designed for use by responders
Terminated
MKJK111693

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