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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)
Oct 18, 2010Defibtech, LLC
DDC-6-AA Data Card, an accessory to the Sentry DDU-1 00 semiautomatic external defibrillator (AED). The DDC-6-AA data card is an accessory to the AED and does not have its own intended use.
Terminated
MKJK013896
Aug 27, 2010Philips Healthcare Inc.
HeartStart MRx Defibrillator/Monitor with Q-CPR Meter option.The HeartStart MRx monitor/defibrillator has an option (Q-CPR Meter) to provide visual and audible feedback to the rescuer on the quality
Terminated
MKJK051134
Jul 1, 2010Physio Control, Inc.
LIFEPAK 20 defibrillator/monitor. Product Part numbers: 3202487-xxx, 3202488-xxx, U3202487-000, 3202488-015, and U3202488-000.
Terminated
MKJK012274
Jun 28, 2010Philips Medical Systems
Automated External Defibrillator (AED) of brand name "Philips HeartStart HS1 Home" (Model Number M5068A). Device is designed for use on a person in sudden cardiac arrest who is unresponsive when sha
Terminated
MKJK020715
K040904
Jun 28, 2010Philips Medical Systems
Automated External Defibrillator(AED) of brand name "Philips HeartStart HS1 OnSite" (Model number M5066A). Device is designed for use on a person in sudden cardiac arrest who is unresponsive when sha
Terminated
MKJK020715
Jun 28, 2010Philips Medical Systems
Automated External Defibrillator (AED) of brand name "Philips HeartStart FRx" (Model number 861304). Device is designed for use on a person in sudden cardiac arrest who is unresponsive when shaken an
Terminated
MKJK050004
Jun 21, 2010Cardiac Science Corporation
Cardiac Science Powerheart 9390A automated external defibrillator. This fully automatic model does not require the user to press a shock button in order for the device to deliver therapy (when approp
Terminated
MKJK031987
Jun 10, 2010Defibtech LLC
ReviveR AED semiautomatic external defibrillator used with the DBP-2800 Battery Pack. Manufactured by Defibtech, LLC. Seymour, CT 06483. The DBP-2800 battery pack is an accessory to the AED and do
Terminated
MKJK013896
Jun 10, 2010Defibtech LLC
Lifeline AED DDU-100 semiautomatic external defibrillator used with the DBP-2800 Battery Pack, Manufactured by Defibtech, LLC. Seymour, CT 06483. The DBP-2800 battery pack is an accessory to the AE
Terminated
MKJK013896
May 26, 2010Cardiac Science Corporation
Responder 2000 Defibrillator/Monitor Models: 2025653, 2026109, and 2026114. Intended use: The Responder 2000 is indicated for the termination of certain fatal arrhythmias, such as ventricular fibrill
Terminated
MKJK060934
May 24, 2010Philips Healthcare Inc.
HeartStart MRx Defibrillator Monitor, Model M3535A HeartStart MRx Defibrillator Monitor, Model M3536A The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibr
Terminated
MKJK051134
May 7, 2010ZOLL Medical Corporation, World Wide Headquarters
ZOLL E Series Defibrillator/Pacemaker/Monitors, BLS Model, with software versions 4.XX, 6.XX and 7.0X. Zoll Medical Corporation, Chelmsford, MA. Intended for the purpose of converting ventricular fi
Terminated
MKJK042007
Apr 27, 2010Cardiac Science Corporation
Cardiac Science, Automated External Defibrillator (AED) under the following brand names (with respective model numbers): Powerheart AED G3: 9300A, 9300C, 9300D, 9300E, 9300P, 9390A/E; CardioVive: 92
Terminated
MKJK031987
Apr 21, 2010Physio Control, Inc.
Biphasic LIFEPAK 15 Monitor/Defibrillator. Manufactured by Physio-Control Inc., a division of Medtronic, Inc. Redmond, Washington USA. The LIFEPAK 15 monitor/defibrillator is a complete acute cardi
Terminated
MKJK082937
Apr 9, 2010Philips Healthcare Inc.
HeartStart MRx Defibrillator Monitor (Models M3535A, M3536A and M3536J) used with Philips 14.8-Volt Lithium Ion Battery (ModeI M3538A). The HeartStart MRx is for use for the termination of ventricula
Terminated
MKJK051134
Apr 8, 2010Philips Healthcare Inc.
HeartStart MRx- AC power module kit. For use for the termination of ventricular tachycardia and ventricular fibrillation.
Terminated
MKJK051134
Apr 8, 2010Philips Healthcare Inc.
HeartStart MRx Defibrillator/Monitor. For use for the termination of ventricular tachycardia and ventricular fibrillation.
Terminated
MKJK051134
Apr 8, 2010Philips Healthcare Inc.
AC power cords manufactured by Electri-Cord with tall bridge design. Used across all Philips product lines, as well as Respironics/Philips products, Dixtel owned products and Dixtal (formerly Novamet
Terminated
MKJK051134
Apr 6, 2010Cardiac Science Corporation
Cardiovive 92532 automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Br
Terminated
MKJK031987
K040438 +3
Apr 6, 2010Cardiac Science Corporation
Responder 2023440 automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). B
Terminated
MKJK031987
K040438 +3
Apr 6, 2010Cardiac Science Corporation
Powerheart 9390E automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Br
Terminated
MKJK031987
K040438 +3
Apr 6, 2010Cardiac Science Corporation
Powerheart 9390A automated external defibrillator. This fully automatic model does not require the user to press a shock button in order for the device to deliver therapy (when appropriate). Brand n
Terminated
MKJK031987
K040438 +3
Apr 6, 2010Cardiac Science Corporation
Powerheart 9300P automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Br
Terminated
MKJK031987
K040438 +3
Apr 6, 2010Cardiac Science Corporation
Powerheart 9300E automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Br
Terminated
MKJK031987
K040438 +3
Apr 6, 2010Cardiac Science Corporation
Powerheart 9300A automated external defibrillator. This fully automatic model does not require the user to press a shock button in order for the device to deliver therapy (when appropriate). Brand na
Terminated
MKJK031987
K040438 +3
Mar 23, 2010Philips Medical Systems
Heartstart (HS1) Laerdal brand onsite Automated External Defibrillator, Model M5067A
Terminated
MKJK020715
Mar 23, 2010Philips Medical Systems
Philips Heartstart (HS1) Onsite Automated External Defibrillator (AED) Catalog number M5066A
Terminated
MKJK020715
Mar 23, 2010Philips Medical Systems
Philips Heartstart FRx automated external defibrillator (AED), Model 861304
Terminated
MKJK050004
Mar 15, 2010Philips Healthcare Inc.
Philips Switched Internal Defibrillator Paddles (used with Philips HeartStart XL and HeartStart MRx monitor/defibrillators) used during open heart surgery. Models: M4741A - Extra Large Switched inte
Terminated
MKJK021453
K031187
Mar 11, 2010Physio-Control, Inc.
The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings within the environmental conditions specified. Product Part Numbers
Terminated
MKJK082937
Mar 4, 2010Cardiac Science Corporation
NK 9200G. CardioLife automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate).
Terminated
MKJK031987
K040438 +1
Mar 4, 2010Cardiac Science Corporation
NK 9231 CardioLife automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate).
Terminated
MKJK031987
K040438 +1
Mar 4, 2010Cardiac Science Corporation
GE Responder 2023440 automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate).
Terminated
MKJK031987
K040438 +1
Mar 4, 2010Cardiac Science Corporation
GE Responder 2019198 automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate).
Terminated
MKJK031987
K040438 +1
Mar 4, 2010Cardiac Science Corporation
Burdick Cardiovive 92533 automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropria
Terminated
MKJK031987
K040438 +1
Mar 4, 2010Cardiac Science Corporation
Burdick Cardiovive 92532 automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropria
Terminated
MKJK031987
K040438 +1
Mar 4, 2010Cardiac Science Corporation
Burdick Cardiovive 92531 automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropria
Terminated
MKJK031987
K040438 +1
Mar 4, 2010Cardiac Science Corporation
Cardiac Science Powerheart 9390E automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when ap
Terminated
MKJK031987
K040438 +1
Mar 4, 2010Cardiac Science Corporation
Cardiac Science Powerheart 9390A automated external defibrillator. This fully automatic model does not require the user to press a shock button in order for the device to deliver therapy (when approp
Terminated
MKJK031987
K040438 +1
Mar 4, 2010Cardiac Science Corporation
Cardiac Science Powerheart 9300P automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when
Terminated
MKJK031987
K040438 +1
Mar 4, 2010Cardiac Science Corporation
Cardiac Science Powerheart 9300E automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when a
Terminated
MKJK031987
K040438 +1
Mar 4, 2010Cardiac Science Corporation
Cardiac Science Powerheart 9300D automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when a
Terminated
MKJK031987
K040438 +1
Mar 4, 2010Cardiac Science Corporation
Cardiac Science Powerheart 9300C automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when a
Terminated
MKJK031987
K040438 +1
Mar 4, 2010Cardiac Science Corporation
Cardiac Science Powerheart 9300A automated external defibrillator. This fully automatic model does not require the user to press a shock button in order for the device to deliver therapy (when approp
Terminated
MKJK031987
K040438 +1
Feb 22, 2010Physio Control, Inc.
Biphasic LIFEPAK 12 defibrillator / monitor.
Terminated
MKJK063510
Dec 23, 2009Philips Healthcare Inc.
Philips HeartStart Vehicle Wall Mount, Model M5528A with Philips HeartStart DC Power Module, Model M5529A. The HeartStart MRx portable external defibrillator has optional accessories which include
Terminated
MKJK051134
Dec 8, 2009Philips Medical Systems
Heartstart FR2+ automated external defibrillator models M3861A and M3841A are NOT equipped with the ECG Module. Model M3861A is under the Philips label and M3841A is under the Laerdal label.
Terminated
MKJK051632
Dec 8, 2009Philips Medical Systems
Heartstart FR2+ automated external defibrillator Models M3860A and M3840A are equipped with an ECG Module. M3860A is under the Philips label and M3840A is under the Laerdal label.
Terminated
MKJK051632
Nov 9, 2009Philips Healthcare Inc.
HeartStart MRx (M3535A/M3536A) Defibrillator/Monitor. The HeartStart MRx/MRxE is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualifie
Terminated
MKJK031187
Sep 29, 2009ZOLL Medical Corporation, World Wide Headquarters
ZOLL R Series Defibrillator/Pacemaker/Monitor Used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing
Terminated
MKJK060559

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