MKJ
ZOLL X SERIES
- Advisory panel
- Cardiovascular
- Total cleared
- 228
Adverse events under product code MKJ
product code MKJ- Death
- 961
- Injury
- 1,070
- Malfunction
- 90,719
- Other
- 8
- Total
- 92,758
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code MKJ
1–100 of 228- K143714 — Powerheart G5 AED
- K150055 — OneStep Pediatric CPR Multi-Function Electrode
- K150198 — CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel
- K142709 — samaritan PAD 450P
- K133659 — HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING
- K133239 — ZOLL E SERIES
- K142430 — LIFEPAK 15 monitor/defibrillator
- K141795 — BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500
- K142915 — ZOLL X Series
- K142803 — Skintact, various other tradenames
- K141231 — ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERY
- K141774 — ZOLL X SERIES
- K133441 — ONESTEP CPR II MULTI-FUNCTION ELECTRODE
- K133484 — ZOLL X SERIES
- K133269 — ZOLL X SERIES
- K131525 — SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
- K122758 — POWERHEART G5 AED
- K131550 — HEART SYNC
- K130684 — PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR
- K131494 — HEART SYNC
- K130454 — LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR
- K123881 — HEARTSINE SAMARITAN PAD 350P
- K130153 — HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST
- K113787 — DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
- K121853 — DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
- K122839 — ZOLL SUREPOWER SINGLE BAY CHARGER
- K120350 — EXTENDED LIFE BATTERY
- K120406 — ZOLL FULLY AUTOMATIC AED PLUS
- K122600 — LIFEPAK 1000 DEFIBRILLATOR
- K120907 — ZOLL R SERIES
- K120536 — HEART SYNC PEDIATRIC PHYSIO AED PAD
- K112761 — ZOLL PROPAQ MD
- K112432 — ZOLL X SERIES
- K110825 — PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS MULTIFUNCTION ELECTRODES
- K111693 — PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR
- K111594 — ZOLL E SERIES
- K102496 — POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUS
- K110978 — ONESTEP PEDIATRIC MFE'S
- K110742 — ONESTEP ADULT MULTI-FUNCTION ELECTRODE
- K110526 — ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE
- K103567 — LIFEPAK 15 MONITOR/DEFIBRILLATOR
- K110361 — ZOLL R SERIES WITH 2010 AHA GUIDELINES SOFTWARE UPDATE
- K110154 — ZOLL AED PLUS WITH 2010 AHA GUIDLINES SOFTWARE UPDATE
- K110168 — ZOLL E SERIES WITH 2010 AHA GUIDLINES SOFTWARE UPDATE
- K103186 — SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES
- K102972 — LIFEPAK 12
- K100565 — DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325
- K091561 — ZOLL AED PLUS VERSION 5.32 SOFTWARE RELEASE
- K092391 — MOBILEAED, MOBILEALS, MOBILEAED+ AND ADVANTAGEAED
- K091265 — ZOLL E SERIES WITH CPRREADYCHARGE
- K092598 — ZOLL E SERIES WITH SPCO/SPMET OPTION
- K090989 — ZOLL R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIES
- K091943 — POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A
- K091548 — AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A
- K081259 — DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
- K082937 — LIFEPAK 15 MONITOR/DEFIBRILLATOR
- K081081 — ZOLL E SERIES WITH BLUETOOTH DIAL UP NETWORKING
- K082090 — 9131 DEFIBRILLATION ELECTRODES
- K081828 — ZOLL R SERIES BLS DEFIBRILLATOR
- K080903 — ZOLL E SERIES WITH INTIBATION ASSIST OPTION
- K082861 — AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3, NON-RECHARGABLE, MODEL 7L561
- K081371 — SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL
- K073089 — LIFEPAK 20E
- K072923 — ZOLL E SERIES DEFIBRILLATOR
- K080232 — ZOLL E SERIES 12SL, ANALYSIS OPTION
- K073716 — LIFE+CEL OR LIFECEL BATTERY
- K080421 — HEART SYNC, MODELS C-100 AND T-100
- K072812 — PHILIPS HEARTSTART SMARTPADS III
- K072596 — LIFE+CEL OR LIFECEL BATTERY PACK, MODEL 5L500
- K062970 — I-PAD
- K072430 — ZOLL PEDIPADZ REDUCED ENERGY ELECTRODE
- K072233 — SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS
- K071025 — ZOLL AEDPRO WITH SEE-THRU CPR, MODEL AEDPRO
- K070455 — ZOLL E SERIES WITH SEE-THRU CPR
- K062537 — ZOLL M SERIES WITH REAL CPR HELP
- K063510 — LIFEPAK 12 DEFIBRILLATOR/MONITOR
- K063375 — HEARTSTART MRX, MODELS M3535A OR M3536A
- K063119 — LIFEPAK 20 DEFIBRILLATOR/ MONITOR
- K062177 — ZOLL E SERIES WITH REAL CPR HELP
- K052465 — REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351
- K062233 — HEARTSTART MRX MONITOR/DEFIBRILLATOR
- K060559 — ZOLL R SERIES DEFIBRILLATOR
- K061707 — HEARTSTART MRX, INVASIVE PRESSURE & TEMPERATURE OPTIONS
- K060934 — MODIFICATION TO POWERHEART ECD
- K052057 — LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
- K052316 — POWERHEART ECD
- K042404 — LIFEPAK, MODEL 1000
- K052161 — POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A)
- K051632 — PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS M3860A, M3861A, M3840A, M3841A
- K051134 — HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A
- K051475 — ZOLL M SERIES 12SL ANALYSIS OPTION
- K051076 — ZOLL STAT*PADZ MWP MULTI-FUNCTION ELECTRODES
- K042007 — ZOLL E SERIES DEFIBRILLATOR
- K050004 — PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304
- K041892 — ZOLL AED PRO EXTERNAL DEFIBRILLATOR
- K042417 — ZOLL M SERIES ETC02 LOFLO OPTION
- K040479 — PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20
- K041883 — SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21
- K042088 — SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301
- K040637 — POWERHEART AED G3 PRO
Data sourced from openFDA. This site is unofficial and independent of the FDA.