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)
Top companies in MKJ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 24, 2009 | Leonhard 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 |
MKJ | K072233 |
| Sep 24, 2009 | Leonhard 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 |
MKJ | K072233 |
| Sep 14, 2009 | Physio 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 |
MKJ | K011144 |
| Jul 24, 2009 | Philips 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 |
MKJ | K031187 |
| Jul 6, 2009 | Welch Allyn Protocol, Inc Welch Allyn AED 10 automatic external defibrillator and MRL Jumpstart (collectively "AED 10") Terminated |
MKJ | K021168 |
| Jun 23, 2009 | Welch Allyn Protocol, Inc Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10") Terminated |
MKJ | K021168 |
| Jun 2, 2009 | Philips 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 |
MKJ | None listed |
| May 19, 2009 | Philips 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 |
MKJ | K021453 |
| Apr 1, 2009 | ZOLL Medical Corporation, World Wide Headquarters Zoll AED Plus Defibrillator Terminated |
MKJ | K033474 |
| Mar 10, 2009 | Welch Allyn Protocol, Inc Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10") Terminated |
MKJ | K021168 |
| Mar 10, 2009 | Welch Allyn Protocol, Inc Welch Allyn AED 10 Automated External Defibrillator Terminated |
MKJ | K021168 |
| Mar 9, 2009 | Welch Allyn Protocol, Inc Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10") Terminated |
MKJ | K021168 |
| Feb 25, 2009 | Cardiac Science Corporation GE Responder 2019198 AED Manufactured for GE Medical Systems Information Technologies by Cardiac Science Corporation, Automated External Defibrillator Terminated |
MKJ | K052161 |
| Feb 25, 2009 | Cardiac Science Corporation Cardio Vive 92532 AED, BURDICK Manufactured by Cardiac Science Corporation, Automated External Defibrillator Terminated |
MKJ | K040438 |
| Feb 25, 2009 | Cardiac Science Corporation Cardiac Science Powerheart Automated External Defibrillator G3 9390E Terminated |
MKJ | K031987 |
| Feb 25, 2009 | Cardiac Science Corporation Cardiac Science Powerheart Automated External Defibrillator G3 9390A Terminated |
MKJ | K031987 |
| Feb 25, 2009 | Cardiac Science Corporation Cardiac Science Powerheart Automated External Defibrillator G3 9300E. Terminated |
MKJ | K031987 |
| Feb 25, 2009 | Cardiac Science Corporation Cardiac Science First Save Automated External Defibrillator G3 9300C Terminated |
MKJ | K031987 |
| Feb 25, 2009 | Cardiac Science Corporation Cardiac Science Powerheart Automated External Defibrillator G3 9300A Terminated |
MKJ | K031987 |
| Oct 30, 2008 | Physio 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 |
MKJ | K011144 |
| Oct 30, 2008 | Physio 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 |
MKJ | K011144 |
| Sep 25, 2008 | Philips 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 |
MKJ | K031187 |
| Sep 21, 2008 | Physio Control, Inc. Physio-Control Lifepak 20 defibrillator/monitor is intended for the termination of certain fatal arrhythmias. Terminated |
MKJ | K012274 |
| Sep 17, 2008 | Cardiac 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 |
MKJ | K010214 |
| Sep 16, 2008 | Physio 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 |
MKJ | K042404 |
| Sep 11, 2008 | Physio 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 |
MKJ | K991910 |
| Aug 24, 2008 | Physio 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 |
MKJ | K890079 K951593 +1 |
| Jul 9, 2008 | Philips 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 |
MKJ | K020715 |
| Jul 9, 2008 | Philips 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 |
MKJ | K020715 K040904 |
| Jun 28, 2008 | ZOLL 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 |
MKJ | K042007 |
| May 21, 2008 | Cardiac Science Corporation 9051 Electrode Adapter; Automated external defibrillator, Used with QUIK-COMBO System; Cardiac Science Corp, Bothell, WA 98021. Terminated |
MKJ | K971149 |
| Mar 29, 2008 | Physio 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 |
MKJ | K012274 |
| Jan 26, 2008 | Exocomm 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 |
MKJ | None listed |
| Jan 26, 2008 | Exocomm 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 |
MKJ | None listed |
| Dec 22, 2007 | BatteryZone, 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 |
MKJ | None listed |
| Dec 22, 2007 | BatteryZone, 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 |
MKJ | None listed |
| Nov 6, 2007 | Welch 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 |
MKJ | K021168 |
| Oct 25, 2007 | Philips Medical Systems HeartStart XL Defibrillator/Monitor, Model: M4735A Terminated |
MKJ | K021453 |
| Sep 19, 2007 | Welch 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 |
MKJ | K002232 |
| Aug 7, 2007 | Philips Medical Systems Philips Medical HeartStartXL Defibrillator/Monitor
Model : M4735A Terminated |
MKJ | K021453 |
| Jun 21, 2007 | Medtronic Emergency Response Systems, Inc. LIFEPAK EXPRESS defibrillator Terminated |
MKJ | K011144 |
| Jun 21, 2007 | Medtronic Emergency Response Systems, Inc. LIFEPAK CR Plus defibrillator Terminated |
MKJ | K011144 |
| Mar 29, 2007 | Medtronic 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 |
MKJ | K011144 |
| Mar 22, 2007 | Philips Medical Systems Philips HeartStart FR2+ Defibrillator
Automated External Defibrillator (AED)
Catalog Numbers: M3860A/M3861A/M3840A/M3841A Terminated |
MKJ | K003565 |
| Mar 8, 2007 | Defibtech, LLC Defibtech Sentry Semi-Automatic External Defibrilator (AED) sold as 'ReviveR AED' brand -Model DDU-100B (version 2.002 and earlier) Terminated |
MKJ | None listed |
| Mar 8, 2007 | Defibtech, LLC Defibtech Sentry Semi-Automatic External Defibrilator (AED) sold as 'Lifeline AED' brand -Model DDU-100A (version 2.002 and earlier) Terminated |
MKJ | K013896 |
| Dec 27, 2006 | Philips Medical Systems HeartStart FR2+ Defibrillator Terminated |
MKJ | K003565 |
| Jul 28, 2006 | Kimberly-Clark Corporation Kimberly-Clark/Ballard medical R2 triangle shaped non-radiolucent multifunction electrode products for adults. Terminated |
MKJ | K935371 |
| Jul 28, 2006 | Kimberly-Clark Corporation Kimberly-Clark/Ballard medical R2 triangle shaped non-radiolucent multifunction electrode products for pediatrics. Terminated |
MKJ | K895729 |
| Jun 22, 2006 | MRL, 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 |
MKJ | K002232 |
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