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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)
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Top companies in MKJ

Company510(k)sRecalls
Physio-Control Corp.1856
Philips Medical Systems1747
Cardiac Science1746
ZOLL Medical Corporation3516
Philips North America, LLC027
Defibtech, LLC719
Philips Healthcare Inc.021
Zoll Medical Corporation, World Wide Headquarters174
Bio-Detek, Inc.108
Heartsine Technologies, Inc.612
DateFirm and productCodeLinked 510(k)
Apr 4, 2006Medtronic Emergency Response Systems, Inc.
LIFEPAK 12 defibrillator/monitor
Terminated		 MKJK010918
Mar 2, 2006Cardiac Science Corporation
Powerheart AED G3 Automated External Defibrillator Model 9300A (Automatic). Cardiac Science AEDs are manufactured by: Manufacturing: Cardiac Science, Inc., 5474 Feltl Road, Minnetonka, MN 55343-79
Terminated		 MKJK040438
Feb 23, 2006Medtronic Emergency Response Systems, Inc.
LIFEPAK EXPRESS defibrillator
Terminated		 MKJNone listed
Feb 23, 2006Medtronic Emergency Response Systems, Inc.
LIFEPAK CR Plus defibrillator
Terminated		 MKJNone listed
Feb 22, 2006Medtronic Emergency Response Systems, Inc.
LIFEPAK 500 automated external defibrillator (AED)
Terminated		 MKJNone listed
Oct 4, 2005Medtronic Emergency Response Systems, Inc.
Hard shell carry case for the LIFEPAK CR Plus.
Terminated		 MKJNone listed
Oct 4, 2005Medtronic Emergency Response Systems, Inc.
Hard shell carry case for the LIFEPAK 500 AED.
Terminated		 MKJK010918
Jul 28, 2005Heartsine Technologies Inc
HeartSine Samaritan AED Defibrillators Models: SAM 001, SAM 002, SAM 003.
Terminated		 MKJK023854
May 17, 2005Philips Medical Systems
Philips Medical HeartStart MRx Monitor/Defibrillator Model: M3535A, M3536A
Terminated		 MKJK031187
May 12, 2005MRL, Inc., A Welch Allyn Company
Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company, 1000 Asbury Drive, Buffalo Grove, Illinois
Terminated		 MKJK002232
Mar 23, 2005Heartsine Technologies Inc
Heartsine Samaritan AED Defibrillators - Models: SAM 001, SAM 002, SAM 003. Serial numbers within range of 1270 - 2324 (not all are affected).
Terminated		 MKJNone listed
Mar 10, 2005Medtronic Emergency Response Systems, Inc.
LIFEPAK 500 AED.
Terminated		 MKJNone listed
Feb 3, 2005Medtronic Emergency Response Systems, Inc.
LIFEPAK 12 defibrillator/ monitors biphasic
Terminated		 MKJK040775
K991910
Jan 15, 2005Cardiac Science, Inc.
Powerheart AED G3 Automated External Defibrillator Model 9300P Professional series). Cardiac Science AEDs are manufactured by: Manufacturing: Cardiac Science, Inc., 5474 Feltl Road, Minnetonka, MN
Terminated		 MKJK040637
Jan 15, 2005Cardiac Science, Inc.
Powerheart AED G3 Automated External Defibrillator Model 9300E. Cardiac Science AEDs are manufactured by: Manufacturing: Cardiac Science, Inc., 5474 Feltl Road, Minnetonka, MN 55343-7982.
Terminated		 MKJK031987
Dec 21, 2004Philips Medical Systems
Philips Heartstart MRx Monitor/Defibrillator Models: M3535A (Hospital Use) , M3536A (EMS Use)
Terminated		 MKJK031187
Nov 20, 2004Access CardioSystems
AccessAED PAD Package (without ECG trace) Model Number: 9100-0015-0
Terminated		 MKJNone listed
Nov 20, 2004Access CardioSystems
AccessAED PAD (without ECG trace) -Public Access Defibrillator Model Number: 9100-0010-0
Terminated		 MKJNone listed
Nov 20, 2004Access CardioSystems
AccessALS Package Model Number: 9100-0150-2
Terminated		 MKJNone listed
Nov 20, 2004Access CardioSystems
AccessALS (Advanced Life Support) Model Number: 9100-0100-2
Terminated		 MKJNone listed
Nov 20, 2004Access CardioSystems
AccessAED Package (with audio record) Model Number: 9100-0150-1
Terminated		 MKJNone listed
Nov 20, 2004Access CardioSystems
AccessAED (with audio record) Model Number: 9100-0100-1
Terminated		 MKJNone listed
Nov 20, 2004Access CardioSystems
AccessAED Package (without audio record) Model Number: 9100-0150-0
Terminated		 MKJNone listed
Nov 20, 2004Access CardioSystems
AccessAED (without audio record) Model Number: 9100-0100-0
Terminated		 MKJK020984
Jul 20, 2004Cardiac Science, Inc.
Power Heart Automatic External Defibrillator, Model 9210 RD
Terminated		 MKJK011901
Jul 20, 2004Cardiac Science, Inc.
FirstSave AED G3 Automated External Defibrillator IntelliSense (Lithium) Battery, Model 9143
Terminated		 MKJK031987
Jul 20, 2004Cardiac Science, Inc.
Power Heart AED G3 Automated External Defibrillator IntelliSense (Lithium) Battery, Model 9142
Terminated		 MKJK031987
Jul 20, 2004Medtronic Physio Control Corp
LIFEPAK 12 defibrillator/monitor Part Numbers: VLP12-02-000000 through VLP12-02-005003, AVLP12-02-000000 through AVLP12-02-005003, DVLP12-02-000000 through DVLP12-02-005003, EVLP12-02-000000 throu
Terminated		 MKJK012274
Jul 20, 2004Cardiac Science, Inc.
Power Heart AED Automatic External Defibrillator, Model 9200 RD
Terminated		 MKJK011901
Jul 20, 2004MRL, Inc., A Welch Allyn Company
Welch Allyn AED 10 Defibrillator; a battery powered automated external defibrillator; Manufacturer: MRL, Inc., A Welch Allyn Company, 100 Asbury Drive, Buffalo Grove, Illinois 60089; Model AED10, part
Terminated		 MKJK021168
Jul 20, 2004Medtronic Physio Control Corp
LIFEPAK 500 automated external defibrillator
Terminated		 MKJK012428
Jul 20, 2004Access CardioSystems
Access AED and Access ALS Automated External Defibrillators Model No. : 9100-0100
Terminated		 MKJK020984
Sep 11, 2003Philips Medical Systems
Model M4735A HeartStart XL Defibrillator//Monitor
Terminated		 MKJK021453
Jul 10, 2003Zoll Medical Corporation
Zoll M Series External Defibrillator
Terminated		 MKJK972241
Jun 12, 2003Medtronic Physio Control Corp
LIFEPAK CR Plus defibrillator
Terminated		 MKJK011144
Feb 6, 2003Zoll Medical Corporation
Zoll AED Plus Defibrillator (Automatic External Defibrillator)
Terminated		 MKJK011388
Feb 5, 2003Medtronic Physio Control Corp
LIFEPAK 12 defibrillator/monitor is a portable, battery operated, complete acute cardiac care response system with both manual and semi-automatic defibrillation operation. It has the ability to exte
Terminated		 MKJK002445
K010918 +3
Dec 18, 2002Philips Medical Systems, Inc. Cardiac & Monitoring Systems
Philips HeartStart XL, Model M4735A Defibrillator/Monitor
Terminated		 MKJK001725
K010634 +1

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