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 |
|---|---|---|---|
| Jul 1, 2004 | K041459 | LIFEPAK 12 DEFIBRILLATOR/MONITOR Medtronic Emergency Response Systems, Inc. | MKJ |
| Jul 1, 2004 | K040438 | POWERHEART AED G3A Cardiac Science, Inc. | MKJ |
| Jun 16, 2004 | K033896 | DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MODELS DDU-100 WITH DDP-200P Defibtech, LLC | MKJ |
| May 25, 2004 | K041067 | HEARTSINE SAMARITAN PAD Heartsine Technologies, Inc. | MKJ |
| May 25, 2004 | K033642 | SMARTLANK WIRELESS, MODEL 001970 Mrl, A Welch Allyn Company | MKJ |
| May 21, 2004 | K033474 | ZOLL AED PLUS Zoll Medical Corp | MKJ |
| May 4, 2004 | K040404 | HEARTSTART MRX, MODEL M3535A Philips Medical Systems, Inc. | MKJ |
| Apr 23, 2004 | K040775 | LIFEPAK 12 Medtronic Physio-Control Corp. | MKJ |
| Apr 9, 2004 | K040256 | PEDI-PADZ RADIOLUCENT MULTI-FUNCTION PEDIATRIC ELECTRODES, MODEL 8900-1005 Bio-Detek, Inc. | MKJ |
| Apr 9, 2004 | K040056 | BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90 Bio-Detek, Inc. | MKJ |
| Feb 27, 2004 | K033771 | BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTOR Bio-Detek, Inc. | MKJ |
| Feb 27, 2004 | K032421 | AMBU PEDIATRIC MULTI-FUNCTION DEFIBRILLATION ELECTRODE Ambu, Inc. | MKJ |
| Jan 9, 2004 | K032051 | BATTERY PACK, RECHARGEABLE, MODELS MLA0051, MLA90479, MNC5169L/P, MNC1000EKG, MNC14649P Access Battery, Inc. | MKJ |
| Nov 13, 2003 | K033144 | DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES Defibtech, LLC | MKJ |
| Nov 6, 2003 | K033275 | LIFEPAK 12, 20, 500, CR PLUS Medtronic Physio-Control Corp. | MKJ |
| Nov 5, 2003 | K032439 | ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC) Zoll Medical Corp | MKJ |
| Aug 27, 2003 | K031187 | HEARTSTART MRX, MODEL M3535A Philips Medical Systems | MKJ |
| Aug 27, 2003 | K030898 | MOBILE BATTERY SERVICE STATION (MBSS) Ad Elektronik GmbH | MKJ |
| Jul 30, 2003 | K031987 | POWERHEART AED G3, MODEL 9300 Cardiac Science | MKJ |
| Feb 14, 2003 | K023854 | SAMARITAN AED, MODEL SAM-01 Heartsine Technologies, Inc. | MKJ |
| Jan 27, 2003 | K022929 | PEDIATRIC ATTENUATED DEFIBRILLATION ELECTRODES, MODEL 9730, POWEDERHEART AED, MODEL 9200/9210 Cardiac Science, Inc. | MKJ |
| Dec 13, 2002 | K022732 | INFANT/CHILD REDUCED ENERGY ELECTRODES Medtronic Physio-Control Corp. | MKJ |
| Nov 8, 2002 | K020715 | PHILIPS M5066A AND M5068A Philips Medical Systems | MKJ |
| Oct 4, 2002 | K022210 | MULTIFUNCTIONAL ELECTRODE MODELS 9640, 9650 Cardiac Science, Inc. | MKJ |
| Aug 14, 2002 | K020984 | ACCESSAED, SEMI-AUTOMATIC EXTERNAL DEFIBRILLATORS Access Cardiosystems, Inc. | MKJ |
| Jul 3, 2002 | K021453 | HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A Philips Medical Systems | MKJ |
| Jun 26, 2002 | K021168 | JUMP START, MODEL 970300 Medical Research Laboratories, Inc. | MKJ |
| Jun 19, 2002 | K013896 | SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECTRODES) DDP-100; BATTERY PACK 1200MAH; BA Defibtech, LLC | MKJ |
| May 28, 2002 | K020743 | PADPRO, MODEL 2502 Padpro, LLC | MKJ |
| May 8, 2002 | K020203 | PADPRO MODEL #2516 Padpro, LLC | MKJ |
| Apr 11, 2002 | K011541 | ZOLL PAD WITH CPR AID Zoll Medical Corp | MKJ |
| Mar 25, 2002 | K011388 | ZOLL PAD Zoll Medical Corp | MKJ |
| Feb 27, 2002 | K020288 | PADPRO, MODEL 2603 Padpro, LLC | MKJ |
| Feb 1, 2002 | K011901 | FIRSTSAVE STAR BIPHASIC, MODEL 9210/9200 Survivalink Corp. | MKJ |
| Jan 23, 2002 | K012766 | PORTABLE INTENSIVE CARE UNIT Medical Research Laboratories, Inc. | MKJ |
| Jan 18, 2002 | K014209 | PADPRO MODEL 2001, 2001-S, 2001-C, 2001-EPS Padpro, LLC | MKJ |
| Jan 17, 2002 | K014157 | HEARTSTREAMFR2 AED WITH M3848A AND M3849A, MODELS M3860A, M3861, M3840A, M3841A Philips Medical Systems | MKJ |
| Jan 14, 2002 | K013425 | HEARTSTREAM/HEARTSTART FR2 AED ECG CABLE, MODELS M3860A, M3861A, M3840A, M3841A Philips Medical Systems | MKJ |
| Dec 3, 2001 | K011144 | LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR Medtronic Physio-Control Corp. | MKJ |
| Nov 16, 2001 | K012197 | POWERHEART CARDIAC RHYTHM MODULE Cardiac Science, Inc. | MKJ |
| Sep 28, 2001 | K012428 | MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR Medtronic Physio-Control Corp. | MKJ |
| Sep 24, 2001 | K012030 | PORTABLE INTENSIVE CARE UNIT Medical Research Laboratories, Inc. | MKJ |
| Sep 4, 2001 | K003548 | PADPRO SYSTEM DEFIBRILLATOR ELECTRODE ADAPTERS Padpro, LLC | MKJ |
| Aug 23, 2001 | K010918 | LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM Medtronic Physio-Control Corp. | MKJ |
| Jun 14, 2001 | K010207 | PORTABLE INSTENSIVE CARE UNIT Medical Research Laboratories, Inc. | MKJ |
| Jun 11, 2001 | K010634 | HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTSTREAM XLT DEFIBRILLATOR/MONITOR.MODEL M2500B Agilent Technologies, Inc. | MKJ |
| May 2, 2001 | K003819 | HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A Agilent Technologies, Inc. | MKJ |
| Feb 28, 2001 | K010257 | ZOLL M SERIES Zoll Medical Corp | MKJ |
| Feb 22, 2001 | K010214 | FIRSTSAVE BIPHASIC MODEL #9200 AND 9210 Survivalink Corp. | MKJ |
| Feb 22, 2001 | K002079 | MULTI-FUNCTION DEFIBRILLATION ELECTRODE Medicotest A/S | MKJ |
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