FDA Product Code MKJ: Automated External Defibrillators (non-wearable)
This Device Is A Non-wearable Prescription Use Only Aed. These Are Devices That Include Automated External Defibrillation. Automated External Defibrillators Use External Pad-type Electrodes To Sense, Detect, Classify And Treat (with An Electrical Shock) Ventricular Fibrillation. These Devices Are Intended To Be Used On Suspected Victims Of Sudden Cardiac Arrest. A Person In Cardiac Arrest Is Unresponsive And Is Not Breathing Normally. The Device Can Be Sold With Prescription Only.
Leading manufacturers include Zoll Medical Corp, Zoll Medical Corporation, World Wide Headquarters and ZOLL Medical Corporation.
228
Total
228
Cleared
156d
Avg days
1985
Since
228 devices
Cleared
Sep 23, 2009
ZOLL R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIES
Zoll Medical Corp
Cardiovascular
169d
Cleared
Mar 09, 2009
ZOLL E SERIES WITH BLUETOOTH DIAL UP NETWORKING
Zoll Medical Corporation, World Wide Headquarters
Cardiovascular
327d
Cleared
Dec 09, 2008
ZOLL R SERIES BLS DEFIBRILLATOR
ZOLL Medical Corporation
Cardiovascular
165d
Cleared
Dec 04, 2008
ZOLL E SERIES WITH INTIBATION ASSIST OPTION
ZOLL Medical Corporation
Cardiovascular
247d
Cleared
Sep 24, 2008
SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL
Leonhard Lang GmbH
Cardiovascular
132d
Cleared
Apr 24, 2008
ZOLL E SERIES DEFIBRILLATOR
Zoll Medical Corporation, World Wide Headquarters
Cardiovascular
192d
Cleared
Apr 23, 2008
ZOLL E SERIES 12SL, ANALYSIS OPTION
Zoll Medical Corporation, World Wide Headquarters
Cardiovascular
84d
Cleared
Feb 26, 2008
PHILIPS HEARTSTART SMARTPADS III
Philips Medical Systems
Cardiovascular
148d
Cleared
Nov 06, 2007
ZOLL PEDIPADZ REDUCED ENERGY ELECTRODE
ZOLL Medical Corporation
Cardiovascular
69d
Cleared
Oct 05, 2007
SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS
Leonhard Lang GmbH
Cardiovascular
56d
Cleared
Jun 22, 2007
ZOLL AEDPRO WITH SEE-THRU CPR, MODEL AEDPRO
Zoll Medical Corporation, World Wide Headquarters
Cardiovascular
72d
Cleared
Apr 26, 2007
ZOLL E SERIES WITH SEE-THRU CPR
Zoll Medical Corporation, World Wide Headquarters
Cardiovascular
69d
Cleared
Feb 28, 2007
ZOLL M SERIES WITH REAL CPR HELP
ZOLL Medical Corporation
Cardiovascular
183d
Cleared
Jan 11, 2007
HEARTSTART MRX, MODELS M3535A OR M3536A
Philips Medical Systems
Cardiovascular
64d
Cleared
Dec 13, 2006
ZOLL E SERIES WITH REAL CPR HELP
ZOLL Medical Corporation
Cardiovascular
135d
Cleared
Dec 12, 2006
REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351
Heartsine Technologies, Inc.
Cardiovascular
460d
Cleared
Nov 22, 2006
HEARTSTART MRX MONITOR/DEFIBRILLATOR
Philips Medical Systems North America, Inc.
Cardiovascular
112d
Cleared
Aug 17, 2006
ZOLL R SERIES DEFIBRILLATOR
ZOLL Medical Corporation
Cardiovascular
168d
Cleared
Aug 11, 2006
HEARTSTART MRX, INVASIVE PRESSURE & TEMPERATURE OPTIONS
Philips Medical Systems
Cardiovascular
56d
Cleared
Feb 17, 2006
LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
Medtronic Emergency Response Systems, Inc.
Cardiovascular
203d
Cleared
Jan 03, 2006
POWERHEART ECD
Cardiac Science, Inc.
Cardiovascular
131d
Cleared
Dec 22, 2005
LIFEPAK, MODEL 1000
Medtronic Emergency Response Systems, Inc.
Cardiovascular
475d
Cleared
Oct 21, 2005
POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A)
Cardiac Science, Inc.
Cardiovascular
73d
Cleared
Oct 05, 2005
PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS M3860A, M3861A, M3840A, M3841A
Philips Medical Systems
Cardiovascular
107d