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 |
|---|---|---|---|
| Feb 5, 2001 | K002280 | PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602 Medical Devices, Inc. | MKJ |
| Jan 31, 2001 | K002445 | LIFEPAK 12DEFIBERLLATOR/MONITOR SERIES Medtronic Physio-Control Corp. | MKJ |
| Dec 20, 2000 | K003565 | HEARTSTREAM FR2 AED, MODEL M3860A,M3861A Agilent Technologies, Inc. | MKJ |
| Dec 14, 2000 | K003228 | K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A Katecho, Inc. | MKJ |
| Dec 6, 2000 | K002232 | AEDEFIBRILLATOR Medical Research Laboratories, Inc. | MKJ |
| Nov 21, 2000 | K002806 | K-DEFIB/PACE, MODEL KDP-60A Katecho, Inc. | MKJ |
| Oct 30, 2000 | K000638 | RESPONDER 3000 Ge Medical Systems Information Technologies GmbH, DE | MKJ |
| Sep 8, 2000 | K001725 | HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A Agilent Technologies, Inc. | MKJ |
| May 18, 2000 | K992543 | HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SINGLE BAY ADAPTER, DEFIBRILLATOR PADS CABLE Hewlett-Packard Co. | MKJ |
| Feb 28, 2000 | K993036 | ZOLL M SERIES ETCO2 OPTION Zoll Medical Corp | MKJ |
| Feb 3, 2000 | K993745 | K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80 Katecho, Inc. | MKJ |
| Jan 24, 2000 | K993533 | POWERHEART AECD Cardiac Science, Inc. | MKJ |
| Dec 10, 1999 | K993072 | SURVIVALINK MULTIFUNCTIONAL ELECTRODE (SVL-9630) Survivalink Corp. | MKJ |
| Dec 1, 1999 | K992977 | HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504A Hewlett-Packard Co. | MKJ |
| Oct 21, 1999 | K991556 | ZOLL M SERIES 12SL ANALYSIS OPTION Zoll Medical Corp | MKJ |
| Sep 3, 1999 | K991910 | LIFEPAK 12 BIPHASIC Physio-Control Corp. | MKJ |
| Sep 3, 1999 | K990762 | ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC) Zoll Medical Corp | MKJ |
| Aug 23, 1999 | K991007 | K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60 Katecho, Inc. | MKJ |
| Aug 5, 1999 | K991871 | HEWLETT PACKARD MULTI FUNCTION ADULT DEFIB ELECTRODE, MODEL M3501A & M3502A Hewlett-Packard Co. | MKJ |
| May 5, 1999 | K983393 | LIFEPAK 500 BIPHASIC Physio-Control Corp. | MKJ |
| Mar 16, 1999 | K984582 | ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX Bio-Detek, Inc. | MKJ |
| Mar 11, 1999 | K982992 | ZOLL M SERIES SPO2 OPTION Zoll Medical Corp | MKJ |
| Feb 26, 1999 | K990106 | ZOLL FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODES Bio-Detek, Inc. | MKJ |
| Jan 25, 1999 | K982264 | FIRSTSAVE BIPHASIC MODELS 9200 AND 9210 Survivalink Corp. | MKJ |
| Dec 17, 1998 | K984286 | HEARTSTREAM ELECTRODE ADAPTER Hewlett-Packard Co. | MKJ |
| Dec 9, 1998 | K981737 | K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60 Katecho, Inc. | MKJ |
| Nov 25, 1998 | K981802 | ZOLL STAT*PADZ ADULT MULTI-FUNCTION ELECTRODES MODEL NUMBER 8900-4003 Bio-Detek, Inc. | MKJ |
| Nov 20, 1998 | K983307 | MODIFICATION TO PORTABLE INTENSIVE CARE UNIT Medical Research Laboratories, Inc. | MKJ |
| Nov 5, 1998 | K983287 | MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE Graphic Controls Corp. | MKJ |
| Sep 4, 1998 | K982025 | HEWLETT-PACKARD M2475B WITH 12-LEAD OPTION (#C90) CODEMASTER 100 CONITOR/DEFIBRILLATOR Hewlett-Packard Co. | MKJ |
| Aug 10, 1998 | K982710 | AECD ARRHYTHMIA DETECTION SOFTWARE Cardiac Science, Inc. | MKJ |
| Jun 26, 1998 | K965117 | LIFE SUPPORT FOR TRAUMA AND TRANSPORT Northrop Grumman Corp. | MKJ |
| May 12, 1998 | K980857 | MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODE Graphic Controls Corp. | MKJ |
| Mar 16, 1998 | K972241 | ZOLL REVIVER Zoll Medical Corp | MKJ |
| Jan 9, 1998 | K973486 | LIFE PAK 12 Physio-Control Corp. | MKJ |
| Nov 6, 1997 | K962359 | LIFEPAK 300 Physio-Control Corp. | MKJ |
| Oct 16, 1997 | K970741 | POWERHEART AECD Cardiac Science, Inc. | MKJ |
| Sep 25, 1997 | K972418 | HEARTSTRAMELECTRODE ADAPTER(EA-XX SERIES)/HEARTSTRAM DEFIBRILLATION PADS WITH PREATTACHED ELECTRODE ADAPTER(DP-EAXX) Heartstream, Inc. | MKJ |
| Aug 27, 1997 | K972970 | MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE Graphic Controls Corp. | MKJ |
| Jul 28, 1997 | K955890 | FIRST MEDIC PULSE OXIMETRY MODULE Colorado Medtech, Inc. | MKJ |
| Jun 23, 1997 | K971149 | SVL-9130 DEFIBRILLATION ELECTRODE Survivalink Corp. | MKJ |
| May 15, 1997 | K971148 | 700-SP SERIES DISPOSABLE STIMULATION ELECTRODES Cardiotronics Systems, Inc. | MKJ |
| Apr 16, 1997 | K970719 | 700-MP DISPOSABLE RADIOLUCENT MULTI-PAD ELECTRODES Cardiotronics Systems, Inc. | MKJ |
| Mar 6, 1997 | K970391 | QUANTUM EDGE PEDIATRIC DEFIRBRILLATION ELECTRODES Contour Medical Technology, Inc. | MKJ |
| Jan 15, 1997 | K964991 | 700-FR SERIES RADIOLUCENT STIMULATION ELECTRODES Cardiotronics Systems, Inc. | MKJ |
| Nov 4, 1996 | K955854 | LIFEPAK 500 Physio-Control Corp. | MKJ |
| Oct 24, 1996 | K955923 | MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR LAERDAL Graphic Controls Corp. | MKJ |
| Oct 24, 1996 | K955882 | MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR HEWLETT PACKARD DEFIBRILLATORS Graphic Controls Corp. | MKJ |
| Sep 10, 1996 | K955628 | FORE RUNNER EXTERNAL DEFIBRILLATOR/DEFIBRILLATOR PADS Heartstream, Inc. | MKJ |
| Jul 25, 1996 | K955828 | MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR PHYSIO CONTROL DEFIBRILLATORS Graphic Controls Corp. | MKJ |
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