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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

DateFirm and productCodeLinked 510(k)
Sep 24, 2009Leonhard Lang Gmbh
S&W Electrodes for Defibrillation, 10 Defibrillation Electrodes, Reorder #90101, S & W Healthcare Corp, 1525 Flight Path Drive Brooksville, Florida 34604 The device is non-sterile and single use. F
Terminated
MKJK072233
Sep 24, 2009Leonhard Lang Gmbh
SKINTACT Electrodes for Defibrillation, 10X REF DF20, Rx only, Manufactured by Leonhard Lang GmbH, Archenweg 56, 6020 Innsbruck, Austria. The device is non-sterile and single use. For use on adults
Terminated
MKJK072233
Sep 14, 2009Physio Control, Inc.
Medtronic Physio-Control LIFEPAK CR Plus Defibrillator/Monitor. Automated external defibrillator deployed primarily in public access defibrillator environments where the expected use for any one devi
Terminated
MKJK011144
Jul 24, 2009Philips Healthcare Inc.
HeartStart MRx/MRxE Defibrillator/Monitor Models: M3536A (HeartStart MRx) and M3536J (HeartStart MRxE). Note: M3536JIMRxE was sold to Japan only. The HeartStart MRx is a lightweight, portable exter
Terminated
MKJK031187
Jul 6, 2009Welch Allyn Protocol, Inc
Welch Allyn AED 10 automatic external defibrillator and MRL Jumpstart (collectively "AED 10")
Terminated
MKJK021168
Jun 23, 2009Welch Allyn Protocol, Inc
Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10")
Terminated
MKJK021168
Jun 2, 2009Philips Healthcare Inc.
HeartStart MRx Defibrillator/Monitor, M3535A/M3536A Is used for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained
Terminated
MKJNone listed
May 19, 2009Philips Healthcare Inc.
HeartStart XL Model M4735A Defibrillator, Automatic, External Defibrillator-Monitor. The defibrillator/monitor is a fully featured defibrillator intended for use by qualified medical personnel train
Terminated
MKJK021453
Apr 1, 2009ZOLL Medical Corporation, World Wide Headquarters
Zoll AED Plus Defibrillator
Terminated
MKJK033474
Mar 10, 2009Welch Allyn Protocol, Inc
Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10")
Terminated
MKJK021168
Mar 10, 2009Welch Allyn Protocol, Inc
Welch Allyn AED 10 Automated External Defibrillator
Terminated
MKJK021168
Mar 9, 2009Welch Allyn Protocol, Inc
Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10")
Terminated
MKJK021168
Feb 25, 2009Cardiac Science Corporation
GE Responder 2019198 AED Manufactured for GE Medical Systems Information Technologies by Cardiac Science Corporation, Automated External Defibrillator
Terminated
MKJK052161
Feb 25, 2009Cardiac Science Corporation
Cardio Vive 92532 AED, BURDICK Manufactured by Cardiac Science Corporation, Automated External Defibrillator
Terminated
MKJK040438
Feb 25, 2009Cardiac Science Corporation
Cardiac Science Powerheart Automated External Defibrillator G3 9390E
Terminated
MKJK031987
Feb 25, 2009Cardiac Science Corporation
Cardiac Science Powerheart Automated External Defibrillator G3 9390A
Terminated
MKJK031987
Feb 25, 2009Cardiac Science Corporation
Cardiac Science Powerheart Automated External Defibrillator G3 9300E.
Terminated
MKJK031987
Feb 25, 2009Cardiac Science Corporation
Cardiac Science First Save Automated External Defibrillator G3 9300C
Terminated
MKJK031987
Feb 25, 2009Cardiac Science Corporation
Cardiac Science Powerheart Automated External Defibrillator G3 9300A
Terminated
MKJK031987
Oct 30, 2008Physio Control, Inc.
LIFEPAK Express Automated External Defibrillator (AED). Labeling on the device states LIFEPAK CR Plus/LIFEPAK EXPRESS Defibrillators with ADAPTIV Biphasic Technology; Medtronic Emergency Response Sys
Terminated
MKJK011144
Oct 30, 2008Physio Control, Inc.
LIFEPAK CR Plus Automated External Defibrillator (AED). Labeling on the device states LIFEPAK CR Plus/LIFEPAK EXPRESS Defibrillators with ADAPTIV Biphasic Technology; Medtronic Emergency Response Sys
Terminated
MKJK011144
Sep 25, 2008Philips Medical Systems
HeartStarMRtX Defibrillator/Monitor Models: M3535A/M3536A HeartStart MRx with a native 256Mbyte internal memory card with date code "0308. The product is used for the termination of ventricular tach
Terminated
MKJK031187
Sep 21, 2008Physio Control, Inc.
Physio-Control Lifepak 20 defibrillator/monitor is intended for the termination of certain fatal arrhythmias.
Terminated
MKJK012274
Sep 17, 2008Cardiac Science Corporation
Electrode Adaptor Cable Quick-Combo System, Model 9055 The 9055 Electrode Adaptor is intended for use by trained personnel who use a Cardiac Science Automated External Defibrillator (AED) for defibril
Terminated
MKJK010214
Sep 16, 2008Physio Control, Inc.
LIFEPAK 1000 defibrillator - portable battery powered semi-automated model that can be operated in either of three modes: Automated external defibrillator (AED), manual defibrillator and electrocardio
Terminated
MKJK042404
Sep 11, 2008Physio Control, Inc.
Physio-Control LIFEPAK 12 defibrillator/monitor. The LIFEPAK12 defibrillator/monitor series is a battery operated portable external defibrillator with monitor used by healthcare providers in EMS, hos
Terminated
MKJK991910
Aug 24, 2008Physio Control, Inc.
FASTPAK batteries labeled Manufactured for Medtronic Physio-Control 11811 Willows Rd, Redmond, WA USA. Batteries are Nickel-Cadmium (NiCd) battery packs used to provide DC power to LIFEPAK 5, 10, 1
Terminated
MKJK890079
K951593 +1
Jul 9, 2008Philips Medical Systems
Laerdal "HeartStart Defibrillator", model M5067A, under Laerdal brand for Laerdal Medical Corp, Wappingers Falls, NY and is sold outside the U.S. The HeartStart is an automated external defibrillator
Terminated
MKJK020715
Jul 9, 2008Philips Medical Systems
Philips defibrillator, model M5066A. Sold in the US by Philips as an OTC under the brand name Philips "HeartStart On Site Defibrillator" and outside the U.S. by Philips with the brand name Philips "H
Terminated
MKJK020715
K040904
Jun 28, 2008ZOLL Medical Corporation, World Wide Headquarters
Zoll E Series Defibrillator with 12 Lead ECG, Automated external defibrillator, Software Version 3.00 and higher; Zoll Medical Corporation, Chelmsford, MA 01824.
Terminated
MKJK042007
May 21, 2008Cardiac Science Corporation
9051 Electrode Adapter; Automated external defibrillator, Used with QUIK-COMBO System; Cardiac Science Corp, Bothell, WA 98021.
Terminated
MKJK971149
Mar 29, 2008Physio Control, Inc.
Physio-Control LIFEPAK 20 defibrillator/monitor, AC powered external defibrillator with battery backup. Part Numbers: 3202487-073, 3202487-079, 3202488-036, Physio Control, Inc, Redmond, WA 98052
Terminated
MKJK012274
Jan 26, 2008Exocomm Tech Grp
life+cel, Replacement battery for Cardiac Science FirstSave Survivalink; OEM P/N:9141-001, Part #: 2L561, Lithium Sulfur Dioxide, Voltage 12V, 7.5 amps., Mfg for Exocomm Technology Group; Mfg by Nordi
Terminated
MKJNone listed
Jan 26, 2008Exocomm Tech Grp
life+cel Replacement Battery for Cardiac Science Powerheart AED G3 OEM P/N: 9146-001, Lithium Sulfur Dioxide, Part # 7L877, Voltage 12V, 7.5 amps; Mfg for Exocomm Technology Group; Mfg by Nordix, Inc.
Terminated
MKJNone listed
Dec 22, 2007BatteryZone, Inc.
life+cel, Replacement battery for Cardiac Science FirstSave Survivalink,Lithium Sulfur Dioxide, Voltage 12V, 7.5 Amps.,OEM P/N: 9141-001,Mfg for Battery Zone, Inc; Mfg by Nordix, Inc.
Terminated
MKJNone listed
Dec 22, 2007BatteryZone, Inc.
life+cel, Replacement Battery for Cardiac Science Powerheart AED G3, Lithium Sulfur Dioxide, OEM P/N: 9146-001, voltage 12V, 7.5 amps, Mfg for Battery Zone, Inc ; Mfg by Nordix, Inc.
Terminated
MKJNone listed
Nov 6, 2007Welch Allyn Protocol, Inc
Welch Allyn AED 10, Automated External Defibrillator, a portable 12V internal battery powered defibrillator; Model AED10; Part Numbers: 970302E,970308E,970309E, 970310E and 970311E;
Terminated
MKJK021168
Oct 25, 2007Philips Medical Systems
HeartStart XL Defibrillator/Monitor, Model: M4735A
Terminated
MKJK021453
Sep 19, 2007Welch Allyn Protocol, Inc
Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company, Buffalo Grove, Illinois; Model AED 20, Cat
Terminated
MKJK002232
Aug 7, 2007Philips Medical Systems
Philips Medical HeartStartXL Defibrillator/Monitor Model : M4735A
Terminated
MKJK021453
Jun 21, 2007Medtronic Emergency Response Systems, Inc.
LIFEPAK EXPRESS defibrillator
Terminated
MKJK011144
Jun 21, 2007Medtronic Emergency Response Systems, Inc.
LIFEPAK CR Plus defibrillator
Terminated
MKJK011144
Mar 29, 2007Medtronic Emergency Response Systems, Inc.
LIFEPAK CR Plus defibrillator. The device is a battery operated, portable automated external defibrillator (AED). The devices are designed for non-professional users and are primarily used in public
Terminated
MKJK011144
Mar 22, 2007Philips Medical Systems
Philips HeartStart FR2+ Defibrillator Automated External Defibrillator (AED) Catalog Numbers: M3860A/M3861A/M3840A/M3841A
Terminated
MKJK003565
Mar 8, 2007Defibtech, LLC
Defibtech Sentry Semi-Automatic External Defibrilator (AED) sold as 'ReviveR AED' brand -Model DDU-100B (version 2.002 and earlier)
Terminated
MKJNone listed
Mar 8, 2007Defibtech, LLC
Defibtech Sentry Semi-Automatic External Defibrilator (AED) sold as 'Lifeline AED' brand -Model DDU-100A (version 2.002 and earlier)
Terminated
MKJK013896
Dec 27, 2006Philips Medical Systems
HeartStart FR2+ Defibrillator
Terminated
MKJK003565
Jul 28, 2006Kimberly-Clark Corporation
Kimberly-Clark/Ballard medical R2 triangle shaped non-radiolucent multifunction electrode products for adults.
Terminated
MKJK935371
Jul 28, 2006Kimberly-Clark Corporation
Kimberly-Clark/Ballard medical R2 triangle shaped non-radiolucent multifunction electrode products for pediatrics.
Terminated
MKJK895729
Jun 22, 2006MRL, 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

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