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 08, 2005
HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A
Philips Medical Systems
Cardiovascular
128d
Cleared
Jun 24, 2005
ZOLL M SERIES 12SL ANALYSIS OPTION
ZOLL Medical Corporation
Cardiovascular
21d
Cleared
May 13, 2005
ZOLL STAT*PADZ MWP MULTI-FUNCTION ELECTRODES
ZOLL Medical Corporation
Cardiovascular
16d
Cleared
Apr 07, 2005
ZOLL E SERIES DEFIBRILLATOR
Zoll Medical Corp
Cardiovascular
255d
Cleared
Feb 25, 2005
PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304
Philips Medical Systems
Cardiovascular
54d
Cleared
Feb 04, 2005
ZOLL AED PRO EXTERNAL DEFIBRILLATOR
ZOLL Medical Corporation
Cardiovascular
206d
Cleared
Oct 05, 2004
ZOLL M SERIES ETC02 LOFLO OPTION
Zoll Medical Corp
Cardiovascular
28d
Cleared
Sep 14, 2004
PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20
Welch Allyn, Inc.
Cardiovascular
202d
Cleared
Sep 07, 2004
SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21
Leonhard Lang GmbH
Cardiovascular
57d
Cleared
Sep 02, 2004
SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301
Heartsine Technologies, Inc.
Cardiovascular
30d
Cleared
Jul 01, 2004
LIFEPAK 12 DEFIBRILLATOR/MONITOR
Medtronic Emergency Response Systems, Inc.
Cardiovascular
29d
Cleared
May 25, 2004
HEARTSINE SAMARITAN PAD
Heartsine Technologies, Inc.
Cardiovascular
32d
Cleared
May 21, 2004
ZOLL AED PLUS
Zoll Medical Corp
Cardiovascular
200d
Cleared
May 04, 2004
HEARTSTART MRX, MODEL M3535A
Philips Medical Systems, Inc.
Cardiovascular
77d
Cleared
Apr 09, 2004
BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90
Bio-Detek, Inc.
Cardiovascular
87d
Cleared
Apr 09, 2004
PEDI-PADZ RADIOLUCENT MULTI-FUNCTION PEDIATRIC ELECTRODES, MODEL 8900-1005
Bio-Detek, Inc.
Cardiovascular
65d
Cleared
Feb 27, 2004
AMBU PEDIATRIC MULTI-FUNCTION DEFIBRILLATION ELECTRODE
Ambu, Inc.
Cardiovascular
206d
Cleared
Feb 27, 2004
BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTOR
Bio-Detek, Inc.
Cardiovascular
86d
Cleared
Nov 05, 2003
ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC)
Zoll Medical Corp
Cardiovascular
90d
Cleared
Aug 27, 2003
HEARTSTART MRX, MODEL M3535A
Philips Medical Systems
Cardiovascular
134d
Cleared
Nov 08, 2002
PHILIPS M5066A AND M5068A
Philips Medical Systems
Cardiovascular
248d
Cleared
Jul 03, 2002
HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A
Philips Medical Systems
Cardiovascular
58d
Cleared
Jun 26, 2002
JUMP START, MODEL 970300
Medical Research Laboratories, Inc.
Cardiovascular
76d
Cleared
Apr 11, 2002
ZOLL PAD WITH CPR AID
Zoll Medical Corp
Cardiovascular
328d