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
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 4, 2015 | K143714 | Powerheart G5 AED Cardiac Science Corporation | MKJ |
| May 2, 2015 | K150198 | CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel Bio-Detek, Inc. | MKJ |
| May 2, 2015 | K150055 | OneStep Pediatric CPR Multi-Function Electrode Bio-Detek, Inc. | MKJ |
| Mar 27, 2015 | K142709 | samaritan PAD 450P Heartsine Technologies, Inc. | MKJ |
| Jan 23, 2015 | K133659 | HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING Philips Medical Systems | MKJ |
| Jan 16, 2015 | K133239 | ZOLL E SERIES Zoll Medical Corporation, World Wide Headquarters | MKJ |
| Dec 19, 2014 | K142430 | LIFEPAK 15 monitor/defibrillator Physio-Control, Inc. | MKJ |
| Dec 8, 2014 | K141795 | BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500 R & D Batteries, Inc. | MKJ |
| Dec 3, 2014 | K142915 | ZOLL X Series ZOLL Medical Corporation | MKJ |
| Dec 2, 2014 | K142803 | Skintact, various other tradenames Leonhard Lang GmbH, AT | MKJ |
| Nov 25, 2014 | K141231 | ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERY Zeller Power Products (Battery Beast, LLC) | MKJ |
| Nov 19, 2014 | K141774 | ZOLL X SERIES ZOLL Medical Corporation | MKJ |
| Oct 10, 2014 | K133441 | ONESTEP CPR II MULTI-FUNCTION ELECTRODE Bio-Detek, Inc. | MKJ |
| Aug 1, 2014 | K133484 | ZOLL X SERIES Zoll Medical Corp | MKJ |
| May 22, 2014 | K133269 | ZOLL X SERIES Zoll Medical Corporation, World Wide Headquarters | MKJ |
| Apr 24, 2014 | K131525 | SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES Defibtech, LLC | MKJ |
| Feb 12, 2014 | K122758 | POWERHEART G5 AED Cardiac Science Corporation | MKJ |
| Dec 6, 2013 | K131550 | HEART SYNC Heart Sync, Inc. | MKJ |
| Oct 18, 2013 | K130684 | PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR Philips Medical Systems | MKJ |
| Sep 16, 2013 | K131494 | HEART SYNC Heart Sync, Inc. | MKJ |
| Aug 21, 2013 | K130454 | LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR Physio-Control, Inc. | MKJ |
| Jul 11, 2013 | K123881 | HEARTSINE SAMARITAN PAD 350P Heartsine Technologies, Inc., IE | MKJ |
| Mar 12, 2013 | K130153 | HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST Philips Medical Systems | MKJ |
| Jan 4, 2013 | K113787 | DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES Defibtech, LLC | MKJ |
| Dec 13, 2012 | K122839 | ZOLL SUREPOWER SINGLE BAY CHARGER ZOLL Medical Corporation | MKJ |
| Dec 13, 2012 | K121853 | DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES Defibtech, LLC | MKJ |
| Nov 1, 2012 | K120350 | EXTENDED LIFE BATTERY Aed Battery Exchange, LLC | MKJ |
| Oct 26, 2012 | K120406 | ZOLL FULLY AUTOMATIC AED PLUS Zoll Medical Corporation, World Wide Headquarters | MKJ |
| Oct 11, 2012 | K122600 | LIFEPAK 1000 DEFIBRILLATOR Physio-Control, Inc. | MKJ |
| Sep 25, 2012 | K120907 | ZOLL R SERIES Zoll Medical Corporation, World Wide Headquarters | MKJ |
| Aug 6, 2012 | K120536 | HEART SYNC PEDIATRIC PHYSIO AED PAD Heart Sync, Inc. | MKJ |
| Apr 25, 2012 | K112761 | ZOLL PROPAQ MD Zoll Medical Corporation, World Wide Headquarters | MKJ |
| Mar 21, 2012 | K112432 | ZOLL X SERIES Zoll Medical Corporation, World Wide Headquarters | MKJ |
| Feb 16, 2012 | K110825 | PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS MULTIFUNCTION ELECTRODES Philips Medical Systems | MKJ |
| Oct 28, 2011 | K111693 | PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR Philips Medical Systems | MKJ |
| Aug 17, 2011 | K111594 | ZOLL E SERIES Zoll Medical Corporation, World Wide Headquarters | MKJ |
| Jun 9, 2011 | K102496 | POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUS Cardiac Science Corporation | MKJ |
| May 13, 2011 | K110978 | ONESTEP PEDIATRIC MFE'S ZOLL Medical Corporation | MKJ |
| Apr 13, 2011 | K110742 | ONESTEP ADULT MULTI-FUNCTION ELECTRODE ZOLL Medical Corporation | MKJ |
| Mar 25, 2011 | K110526 | ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE ZOLL Medical Corporation | MKJ |
| Mar 22, 2011 | K103567 | LIFEPAK 15 MONITOR/DEFIBRILLATOR Physio-Control, Inc. | MKJ |
| Mar 8, 2011 | K110361 | ZOLL R SERIES WITH 2010 AHA GUIDELINES SOFTWARE UPDATE Zoll Medical Corporation, World Wide Headquarters | MKJ |
| Feb 17, 2011 | K110168 | ZOLL E SERIES WITH 2010 AHA GUIDLINES SOFTWARE UPDATE Zoll Medical Corporation, World Wide Headquarters | MKJ |
| Feb 17, 2011 | K110154 | ZOLL AED PLUS WITH 2010 AHA GUIDLINES SOFTWARE UPDATE Zoll Medical Corporation, World Wide Headquarters | MKJ |
| Feb 8, 2011 | K103186 | SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES Leonhard Lang GmbH | MKJ |
| Dec 22, 2010 | K102972 | LIFEPAK 12 Physio-Control, Inc. | MKJ |
| Nov 16, 2010 | K100565 | DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325 Bio-Detek, Inc. | MKJ |
| Sep 23, 2010 | K091561 | ZOLL AED PLUS VERSION 5.32 SOFTWARE RELEASE ZOLL Medical Corporation | MKJ |
| Apr 1, 2010 | K092391 | MOBILEAED, MOBILEALS, MOBILEAED+ AND ADVANTAGEAED Concord Medical Products | MKJ |
| Dec 23, 2009 | K091265 | ZOLL E SERIES WITH CPRREADYCHARGE Zoll Medical Corporation, World Wide Headquarters | MKJ |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.