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 |
|---|---|---|---|
| Dec 3, 2009 | K092598 | ZOLL E SERIES WITH SPCO/SPMET OPTION Zoll Medical Corporation, World Wide Headquarters | MKJ |
| Sep 23, 2009 | K090989 | ZOLL R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIES Zoll Medical Corp | MKJ |
| Sep 10, 2009 | K091943 | POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A Cardiac Science Corporation | MKJ |
| Aug 7, 2009 | K091548 | AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A Amco International Manufacturing & Design, Inc. | MKJ |
| Jun 15, 2009 | K081259 | DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES Defibtech, LLC | MKJ |
| Mar 11, 2009 | K082937 | LIFEPAK 15 MONITOR/DEFIBRILLATOR Physio-Control, Inc. | MKJ |
| Mar 9, 2009 | K081081 | ZOLL E SERIES WITH BLUETOOTH DIAL UP NETWORKING Zoll Medical Corporation, World Wide Headquarters | MKJ |
| Dec 12, 2008 | K082090 | 9131 DEFIBRILLATION ELECTRODES Cardiac Science Corporation | MKJ |
| Dec 9, 2008 | K081828 | ZOLL R SERIES BLS DEFIBRILLATOR ZOLL Medical Corporation | MKJ |
| Dec 4, 2008 | K080903 | ZOLL E SERIES WITH INTIBATION ASSIST OPTION ZOLL Medical Corporation | MKJ |
| Nov 25, 2008 | K082861 | AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3, NON-RECHARGABLE, MODEL 7L561 Amco International Manufacturing & Design, Inc. | MKJ |
| Sep 24, 2008 | K081371 | SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL Leonhard Lang GmbH | MKJ |
| Jul 29, 2008 | K073089 | LIFEPAK 20E Physio-Control, Inc. | MKJ |
| Apr 24, 2008 | K072923 | ZOLL E SERIES DEFIBRILLATOR Zoll Medical Corporation, World Wide Headquarters | MKJ |
| Apr 23, 2008 | K080232 | ZOLL E SERIES 12SL, ANALYSIS OPTION Zoll Medical Corporation, World Wide Headquarters | MKJ |
| Apr 11, 2008 | K073716 | LIFE+CEL OR LIFECEL BATTERY Amco International Manufacturing & Design, Inc. | MKJ |
| Feb 29, 2008 | K080421 | HEART SYNC, MODELS C-100 AND T-100 Heart Sync, LLC | MKJ |
| Feb 26, 2008 | K072812 | PHILIPS HEARTSTART SMARTPADS III Philips Medical Systems | MKJ |
| Jan 24, 2008 | K072596 | LIFE+CEL OR LIFECEL BATTERY PACK, MODEL 5L500 Amco International Manufacturing & Design, Inc. | MKJ |
| Jan 22, 2008 | K062970 | I-PAD Cu Medical Systems, Inc. | MKJ |
| Nov 6, 2007 | K072430 | ZOLL PEDIPADZ REDUCED ENERGY ELECTRODE ZOLL Medical Corporation | MKJ |
| Oct 5, 2007 | K072233 | SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS Leonhard Lang GmbH | MKJ |
| Jun 22, 2007 | K071025 | ZOLL AEDPRO WITH SEE-THRU CPR, MODEL AEDPRO Zoll Medical Corporation, World Wide Headquarters | MKJ |
| Apr 26, 2007 | K070455 | ZOLL E SERIES WITH SEE-THRU CPR Zoll Medical Corporation, World Wide Headquarters | MKJ |
| Feb 28, 2007 | K062537 | ZOLL M SERIES WITH REAL CPR HELP ZOLL Medical Corporation | MKJ |
| Jan 26, 2007 | K063510 | LIFEPAK 12 DEFIBRILLATOR/MONITOR Medtronic Emergency Response Systems, Inc. | MKJ |
| Jan 11, 2007 | K063375 | HEARTSTART MRX, MODELS M3535A OR M3536A Philips Medical Systems | MKJ |
| Dec 22, 2006 | K063119 | LIFEPAK 20 DEFIBRILLATOR/ MONITOR Medtronic Emergency Response Systems, Inc. | MKJ |
| Dec 13, 2006 | K062177 | ZOLL E SERIES WITH REAL CPR HELP ZOLL Medical Corporation | MKJ |
| Dec 12, 2006 | K052465 | REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351 Heartsine Technologies, Inc. | MKJ |
| Nov 22, 2006 | K062233 | HEARTSTART MRX MONITOR/DEFIBRILLATOR Philips Medical Systems North America, Inc. | MKJ |
| Aug 17, 2006 | K060559 | ZOLL R SERIES DEFIBRILLATOR ZOLL Medical Corporation | MKJ |
| Aug 11, 2006 | K061707 | HEARTSTART MRX, INVASIVE PRESSURE & TEMPERATURE OPTIONS Philips Medical Systems | MKJ |
| May 15, 2006 | K060934 | MODIFICATION TO POWERHEART ECD Cardiac Science Corporation | MKJ |
| Feb 17, 2006 | K052057 | LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR Medtronic Emergency Response Systems, Inc. | MKJ |
| Jan 3, 2006 | K052316 | POWERHEART ECD Cardiac Science, Inc. | MKJ |
| Dec 22, 2005 | K042404 | LIFEPAK, MODEL 1000 Medtronic Emergency Response Systems, Inc. | MKJ |
| Oct 21, 2005 | K052161 | POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A) Cardiac Science, Inc. | MKJ |
| Oct 5, 2005 | K051632 | PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS M3860A, M3861A, M3840A, M3841A Philips Medical Systems | MKJ |
| Sep 8, 2005 | K051134 | HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A Philips Medical Systems | MKJ |
| Jun 24, 2005 | K051475 | ZOLL M SERIES 12SL ANALYSIS OPTION ZOLL Medical Corporation | MKJ |
| May 13, 2005 | K051076 | ZOLL STAT*PADZ MWP MULTI-FUNCTION ELECTRODES ZOLL Medical Corporation | MKJ |
| Apr 7, 2005 | K042007 | ZOLL E SERIES DEFIBRILLATOR Zoll Medical Corp | MKJ |
| Feb 25, 2005 | K050004 | PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304 Philips Medical Systems | MKJ |
| Feb 4, 2005 | K041892 | ZOLL AED PRO EXTERNAL DEFIBRILLATOR ZOLL Medical Corporation | MKJ |
| Oct 5, 2004 | K042417 | ZOLL M SERIES ETC02 LOFLO OPTION Zoll Medical Corp | MKJ |
| Sep 14, 2004 | K040479 | PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20 Welch Allyn, Inc. | MKJ |
| Sep 7, 2004 | K041883 | SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21 Leonhard Lang GmbH | MKJ |
| Sep 2, 2004 | K042088 | SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301 Heartsine Technologies, Inc. | MKJ |
| Aug 6, 2004 | K040637 | POWERHEART AED G3 PRO Cardiac Science, Inc. | MKJ |
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