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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 8, 2021Philips North America LLC
Philips, HeartStart HS1 Home Defibrillator, Model # Model number: M5068A
Open, Classified
MKJNone listed
Oct 8, 2021Philips North America LLC
Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304
Open, Classified
MKJNone listed
Oct 8, 2021Philips North America LLC
Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A
Open, Classified
MKJK051632
Sep 3, 2021Philips North America LLC
Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 YEARS)< 55 lbs / 25 kg, CE 0123, NON-STERILE, Rx only, UDI: (01) 00884838023758 for use with defibrillator
Terminated
MKJNone listed
Jan 14, 2021Physio-Control, Inc.
PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 defibrillator is designed for indoor and outdoor use in a stationary environment. After the electrode pads are applied, the full
Open, Classified
MKJNone listed
Sep 14, 2020Philips North America, LLC
Philips Sterilizable Defibrillator Paddles, Switchless Internal Paddles, Model Numbers M1741A, M1742A, M1743A, M1744A - Product Usage: used in pairs to transmit a controlled electrical shock from an e
Terminated
MKJK031187
Sep 14, 2020Philips North America, LLC
Philips Sterilizable Defibrillator Paddles, Switched Internal Paddles, Model Numbers M4741A, M4742A, M4743A, M4744A - Product Usage: used in pairs to transmit a controlled electrical shock from an ext
Terminated
MKJK031187
Jul 16, 2020Philips North America, LLC
Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9 - Product Usage: is intended
Terminated
MKJK031187
Apr 27, 2020Defibtech, LLC
DDU-2450 Lifeline ECG Model Numbers DDU-A2450EN DDU-E2450DE DDU-E2450EN DDU-E2450FR DDU-E2450TH Cat. No. DCF-A2460EN DCF-A2463EN DCF-E2460DE DCF-E2460EN DCF-E2460FR DCF-E2460TH UDI 00815098020287,
Terminated
MKJNone listed
Apr 27, 2020Defibtech, LLC
DDU-2400EN Lifeline PRO, UDI 00815098020270 - Product Usage: Automated External Defibrillators (AED) are indicated for use on victims of sudden cardiac arrest (SCA) who are: - unconscious and unrespon
Terminated
MKJNone listed
Apr 27, 2020Defibtech, LLC
DDU-2300 Lifeline/ReviveR View, Model Numbers DDU-C2300EN, DDU-C2300CA, DDU-A2300EN, DDU-E2300EN Catalog Numbers CCD-A1006RX CCD-A1013EN CCD-A1015EN DCF-A2310EN DCF-A2310RX DCF-A2313EN DCF-C2310CA DC
Terminated
MKJNone listed
Apr 27, 2020Philips North America, LLC
Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for the termination of ventricular tachycardia and ventricular fibrillation.
Terminated
MKJK051134
Apr 24, 2020Physio-Control, Inc.
Infant Child Starter Kits, Part Number: 3202784-009, containing Infant/Child Reduced Energy Defibrillation Electrodes, for use with LIFEPAK 1000 defibrillator, LIFEPAK 500 defibrillator, and LIFEPAK
Terminated
MKJK022732
Apr 24, 2020Physio-Control, Inc.
Infant/Child Reduced Energy Defibrillation Electrodes, Part Number: 3202380-006, for use with LIFEPAK 1000 defibrillator, LIFEPAK 500 defibrillator, and LIFEPAK CR Plus/EXPRESS defibrillator - Product
Terminated
MKJK022732
Apr 21, 2020Philips North America, LLC
Philips HeartStart XL Monitor/Defibrillators Model number: M4735A - Product Usage: is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by tra
Terminated
MKJNone listed
Apr 20, 2020Philips North America, LLC
Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an accessory to the compatible monitor/defibrillator Switchless: M1741A, M1742A, M1743A, M1744A Switched: M4741A, M4742A, M
Terminated
MKJK021453
Apr 13, 2020Philips North America, LLC
Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by tra
Terminated
MKJK001725
Apr 10, 2020Philips North America, LLC
HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the Philips HeartStart MRx Monitorl/Defibrillator - Product Usage: is intended for use in hospital and prehospital sett
Terminated
MKJK063375
Apr 1, 2020Physio-Control, Inc.
LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX, 3011790-XXX/, U3011790-XXX - Product Usage: The LIFEPAK 500 AED is a semi-automatic defibrillator that uses a pa
Terminated
MKJK012428
K052057 +2
Feb 26, 2020Philips North America, LLC
HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, and M3536M9.
Terminated
MKJK063375
Jan 14, 2020Philips North America, LLC
Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart MRx Monitor/Defibrillator - Product Usage: is intended to be used with the M3536A MRx in EMS environments.
Terminated
MKJK063375
Dec 20, 2019Physio-Control, Inc.
LIFEPAK 15 MONITOR/DEFIBRILLATOR service kits
Terminated
MKJK142430
Dec 20, 2019Physio-Control, Inc.
LIFEPAK 15 MONITOR/DEFIBRILLATOR that was either manufactured with or received an upgrade kit that contained an affected keypad.
Terminated
MKJK142430
Nov 19, 2019Philips North America, LLC
HeartStart XL+ Defibrillator/Monitor, Model 861290
Terminated
MKJK110825
Oct 3, 2019Philips North America, LLC
HeartStart XL+ Defibrillator/Monitor, Model 861290
Terminated
MKJK110825
Sep 10, 2019Philips North America LLC
Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED, Model 861304, HSI codeRev: E.03.063
Terminated
MKJK020715
K040904 +1
Sep 10, 2019Philips North America LLC
Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017
Terminated
MKJK020715
K040904 +1
Jul 16, 2019Philips North America, LLC
HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The HeartStart MRx is a lightweight, portable external defibrillator, offering two modes of operation for defibrillation: manual mo
Terminated
MKJK063375
Jul 5, 2019Philips North America, LLC
Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9
Terminated
MKJK063375
Jun 12, 2019ZOLL Medical Corporation
ZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO unit is intended to defibrillate victims of ventricular fibrillation or pulseless ventricular tachycardia, for ECG monitoring,
Open, Classified
MKJNone listed
Jun 4, 2019Cardiac Science Corporation
Powerheart G5 Automatic AED
Terminated
MKJNone listed
Feb 26, 2019Physio-Control Inc
LIFEPAK 15 Monitor/Defibrillator service kits Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardiac care response system designed for basic life support (BLS) and
Terminated
MKJK142430
Feb 26, 2019Physio-Control Inc
LIFEPAK 15 Monitor/Defibrillator Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life
Terminated
MKJK142430
Nov 23, 2018Philips North America LLC
HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a component of HeartStart MRx Monitor/Defibrillators.
Terminated
MKJK051134
Oct 10, 2018Philips Electronics North America Corp.
Philips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage: The HeartStart FR3 is used to treat suspected victims of ventricular fibrillation (VF), the most common cause of sudden card
Terminated
MKJNone listed
Aug 8, 2018Philips North America LLC
Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758
Terminated
MKJK020715
May 3, 2018Philips Electronics North America Corporation
HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) Product Automated external defibrillators (non-wearable) Product Usage: The HeartStart MRx is for use for the termina
Terminated
MKJK063375
Mar 14, 2018Philips Electronics North America Corp.
Philips HeartStart (HS1) Onsite/Home AED
Terminated
MKJK020715
Mar 14, 2018Philips Electronics North America Corp.
Philips HeartStart FRx AED.
Terminated
MKJK050004
Feb 23, 2018ConMed Corporation
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, ZOLL Connector, REF/Catalog Number 2602Z Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable
Terminated
MKJK002280
Feb 23, 2018ConMed Corporation
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control Quik-Combo" Connector, REF/Catalog Number 2602M Indicated for use in external pacing, defibrillation and monitoring applications as a no
Terminated
MKJK002280
Feb 23, 2018ConMed Corporation
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H Indicated for use in external pacing, defibrillation and monitoring applications as a non-steril
Terminated
MKJK002280
Feb 23, 2018ConMed Corporation
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H Indicated for use in external pacing, defibrillation and monitoring applications as a non-steril
Terminated
MKJK002280
Feb 23, 2018ConMed Corporation
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF/Catalog Number 2602 Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile,
Terminated
MKJK002280
Feb 8, 2018Philips North America, LLC
MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. T
Terminated
MKJK031187
K040404 +3
Feb 7, 2018Philips Electronics North America Corporation
HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in ba
Terminated
MKJK110825
Jan 11, 2018Physio-Control, Inc.
LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e defibrillator/monitor is intended for use in the hospital, physician s office, and clinic setting by personnel who are author
Terminated
MKJK130454
Dec 12, 2017Physio-Control, Inc.
LIFEPAK(R) Electrode Starter Kits, Catalog # 11101-000017, MIN #3202784-009 The defibrillation electrodes are used only with LIFEPAK EXPRESS(R) AED, LIFEPAK CR(R) Plus AED, LIFEPAK 1000 defibrillato
Terminated
MKJK022732
Dec 12, 2017Physio-Control, Inc.
LIFEPAK(R) defibrillation electrodes, Catalog # 11101-000016, MIN #3202380-006 The defibrillation electrodes are used only with LIFEPAK EXPRESS(R) AED, LIFEPAK CR(R) Plus AED, LIFEPAK 1000 defibrill
Terminated
MKJK022732
Sep 12, 2017Leonhard Lang Medizintechnik GmbH
Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is n
Terminated
MKJK142803

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