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) |
|---|---|---|---|
| Aug 4, 2017 | ZOLL 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 |
MKJ | K110742 |
| Jul 17, 2017 | Philips 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 |
MKJ | K031187 K040404 +3 |
| Mar 24, 2017 | Philips North America, LLC HeartStart MRx Monitor/Defibrillator,
Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9 Terminated |
MKJ | K031187 K040404 +3 |
| Mar 3, 2017 | Physio-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 |
MKJ | K122600 |
| Feb 11, 2017 | Physio-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 |
MKJ | K142430 |
| Jan 16, 2017 | Physio-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 |
MKJ | K142430 |
| Jan 16, 2017 | Physio-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 |
MKJ | K102972 |
| Oct 14, 2016 | Leonhard 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 |
MKJ | K142803 |
| Aug 26, 2016 | Philips Electronics North America Corporation HeartStart MRx Monitor/Defibrillator
Models: M3535A and M3536A Terminated |
MKJ | K031187 K040404 +3 |
| Jun 15, 2016 | Physio-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 |
MKJ | K142430 |
| May 25, 2016 | Physio-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 |
MKJ | K033275 |
| Apr 14, 2016 | Philips 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 |
MKJ | K031187 K040404 +4 |
| Mar 9, 2016 | Cardiac 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 |
MKJ | K102496 |
| Nov 20, 2015 | Philips 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 |
MKJ | K031187 K040404 +3 |
| Nov 13, 2015 | Philips 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 |
MKJ | K031187 K040404 +2 |
| Nov 10, 2015 | Philips 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 |
MKJ | K031187 K040404 +3 |
| Nov 5, 2015 | Philips 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 |
MKJ | K031187 K040404 +4 |
| Nov 3, 2015 | Philips Medical Systems, Inc. Philips HeartStart MRx Monitor/Defibrillators
Models: M3535A and M3536A Terminated |
MKJ | K031187 K040404 +4 |
| Sep 2, 2015 | Covidien LLC Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak Preconnect System
Item Code:PM20022 Terminated |
MKJ | K960329 |
| Aug 4, 2015 | Philips 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 |
MKJ | K110825 |
| Jan 13, 2015 | Philips 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 |
MKJ | K031187 K040404 +4 |
| Dec 24, 2014 | Heart 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 |
MKJ | K080421 |
| Dec 24, 2014 | Heart 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 |
MKJ | K080421 |
| Dec 24, 2014 | Heart 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 |
MKJ | K080421 |
| Dec 24, 2014 | Heart 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 |
MKJ | K080421 |
| Dec 24, 2014 | Heart 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 |
MKJ | K080421 |
| Dec 19, 2014 | Leonhard 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 |
MKJ | K081371 |
| Dec 4, 2014 | ConMed 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 |
MKJ | K002280 |
| Dec 4, 2014 | ConMed Corporation PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2603H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR Terminated |
MKJ | K020288 |
| Dec 4, 2014 | ConMed Corporation ADULT Radiotransparent Electrode, REF/Catalog Number 2516H-PC, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR Terminated |
MKJ | K020203 |
| Dec 4, 2014 | ConMed Corporation ADULT Radiotransparent Electrode, REF/Catalog Number 2516H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR Terminated |
MKJ | K020203 |
| Dec 4, 2014 | ConMed Corporation ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-PC, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR Terminated |
MKJ | K014209 |
| Dec 4, 2014 | ConMed Corporation ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-C, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR Terminated |
MKJ | K014209 |
| Dec 4, 2014 | ConMed 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 |
MKJ | K014209 |
| Oct 15, 2014 | Covidien LLC MediChoice Multifunction Electrode
Part Number: MC171 OH Terminated |
MKJ | K955882 |
| Oct 15, 2014 | Covidien LLC Covidien Kendall 1710H Multi-Function Defibrillation Electrodes
Part Number: 40000006 Terminated |
MKJ | K955882 |
| Oct 9, 2014 | Bio-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 |
MKJ | K943698 |
| Oct 9, 2014 | Bio-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 |
MKJ | K943698 |
| Oct 9, 2014 | Bio-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 |
MKJ | K943698 |
| Oct 9, 2014 | Bio-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 |
MKJ | K943698 |
| Sep 17, 2014 | Bio-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 |
MKJ | K943698 |
| Sep 17, 2014 | Bio-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 |
MKJ | K943698 |
| Sep 17, 2014 | Bio-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 |
MKJ | K943698 |
| Sep 2, 2014 | Bio-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 |
MKJ | K033771 |
| Jul 24, 2014 | Heartsine 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 |
MKJ | K052465 K123881 |
| May 23, 2014 | Physio-Control, Inc. LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX
The LP1000 (in AED mode) is indicated for use on patients in cardiac arrest. Terminated |
MKJ | K042404 |
| Apr 9, 2014 | Philips 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 |
MKJ | K110825 |
| Apr 9, 2014 | Philips Medical Systems, Inc. Philips HeartStart XL+ Defibrillator/Monitor
Model number: 861290, automatic external defibrillator. Terminated |
MKJ | K110825 |
| Mar 31, 2014 | ZOLL 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 |
MKJ | K112432 K112761 +1 |
| Mar 19, 2014 | Philips 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 |
MKJ | K111693 |
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