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
Dec 13, 2012
DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
Defibtech, LLC
Cardiovascular
171d
Cleared
Dec 13, 2012
ZOLL SUREPOWER SINGLE BAY CHARGER
ZOLL Medical Corporation
Cardiovascular
87d
Cleared
Nov 01, 2012
EXTENDED LIFE BATTERY
Aed Battery Exchange, LLC
Cardiovascular
269d
Cleared
Oct 26, 2012
ZOLL FULLY AUTOMATIC AED PLUS
Zoll Medical Corporation, World Wide Headquarters
Cardiovascular
260d
Cleared
Oct 11, 2012
LIFEPAK 1000 DEFIBRILLATOR
Physio-Control, Inc.
Cardiovascular
45d
Cleared
Sep 25, 2012
ZOLL R SERIES
Zoll Medical Corporation, World Wide Headquarters
Cardiovascular
183d
Cleared
Aug 06, 2012
HEART SYNC PEDIATRIC PHYSIO AED PAD
Heart Sync, Inc.
Cardiovascular
166d
Cleared
Apr 25, 2012
ZOLL PROPAQ MD
Zoll Medical Corporation, World Wide Headquarters
Cardiovascular
216d
Cleared
Mar 21, 2012
ZOLL X SERIES
Zoll Medical Corporation, World Wide Headquarters
Cardiovascular
211d
Cleared
Feb 16, 2012
PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS MULTIFUNCTION ELECTRODES
Philips Medical Systems
Cardiovascular
330d
Cleared
Oct 28, 2011
PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR
Philips Medical Systems
Cardiovascular
134d
Cleared
Aug 17, 2011
ZOLL E SERIES
Zoll Medical Corporation, World Wide Headquarters
Cardiovascular
71d
Cleared
May 13, 2011
ONESTEP PEDIATRIC MFE'S
ZOLL Medical Corporation
Cardiovascular
36d
Cleared
Apr 13, 2011
ONESTEP ADULT MULTI-FUNCTION ELECTRODE
ZOLL Medical Corporation
Cardiovascular
27d
Cleared
Mar 25, 2011
ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE
ZOLL Medical Corporation
Cardiovascular
29d
Cleared
Mar 22, 2011
LIFEPAK 15 MONITOR/DEFIBRILLATOR
Physio-Control, Inc.
Cardiovascular
106d
Cleared
Mar 08, 2011
ZOLL R SERIES WITH 2010 AHA GUIDELINES SOFTWARE UPDATE
Zoll Medical Corporation, World Wide Headquarters
Cardiovascular
29d
Cleared
Feb 17, 2011
ZOLL AED PLUS WITH 2010 AHA GUIDLINES SOFTWARE UPDATE
Zoll Medical Corporation, World Wide Headquarters
Cardiovascular
29d
Cleared
Feb 17, 2011
ZOLL E SERIES WITH 2010 AHA GUIDLINES SOFTWARE UPDATE
Zoll Medical Corporation, World Wide Headquarters
Cardiovascular
28d
Cleared
Feb 08, 2011
SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES
Leonhard Lang GmbH
Cardiovascular
102d
Cleared
Nov 16, 2010
DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325
Bio-Detek, Inc.
Cardiovascular
260d
Cleared
Sep 23, 2010
ZOLL AED PLUS VERSION 5.32 SOFTWARE RELEASE
ZOLL Medical Corporation
Cardiovascular
483d
Cleared
Dec 23, 2009
ZOLL E SERIES WITH CPRREADYCHARGE
Zoll Medical Corporation, World Wide Headquarters
Cardiovascular
237d
Cleared
Dec 03, 2009
ZOLL E SERIES WITH SPCO/SPMET OPTION
Zoll Medical Corporation, World Wide Headquarters
Cardiovascular
101d