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) |
|---|---|---|---|
| Oct 8, 2021 | Philips North America LLC Philips, HeartStart HS1 Home Defibrillator, Model # Model number: M5068A Open, Classified |
MKJ | None listed |
| Oct 8, 2021 | Philips North America LLC Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304 Open, Classified |
MKJ | None listed |
| Oct 8, 2021 | Philips North America LLC Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A Open, Classified |
MKJ | K051632 |
| Sep 3, 2021 | Philips 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 |
MKJ | None listed |
| Jan 14, 2021 | Physio-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 |
MKJ | None listed |
| Sep 14, 2020 | Philips 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 |
MKJ | K031187 |
| Sep 14, 2020 | Philips 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 |
MKJ | K031187 |
| Jul 16, 2020 | Philips 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 |
MKJ | K031187 |
| Apr 27, 2020 | Defibtech, 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 |
MKJ | None listed |
| Apr 27, 2020 | Defibtech, 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 |
MKJ | None listed |
| Apr 27, 2020 | Defibtech, 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 |
MKJ | None listed |
| Apr 27, 2020 | Philips 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 |
MKJ | K051134 |
| Apr 24, 2020 | Physio-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 |
MKJ | K022732 |
| Apr 24, 2020 | Physio-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 |
MKJ | K022732 |
| Apr 21, 2020 | Philips 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 |
MKJ | None listed |
| Apr 20, 2020 | Philips 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 |
MKJ | K021453 |
| Apr 13, 2020 | Philips 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 |
MKJ | K001725 |
| Apr 10, 2020 | Philips 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 |
MKJ | K063375 |
| Apr 1, 2020 | Physio-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 |
MKJ | K012428 K052057 +2 |
| Feb 26, 2020 | Philips North America, LLC HeartStart MRx Monitor/Defibrillators with model numbers M3535A
M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5,
M3536M6, M3536M7, M3536M8, and M3536M9. Terminated |
MKJ | K063375 |
| Jan 14, 2020 | Philips 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 |
MKJ | K063375 |
| Dec 20, 2019 | Physio-Control, Inc. LIFEPAK 15 MONITOR/DEFIBRILLATOR service kits Terminated |
MKJ | K142430 |
| Dec 20, 2019 | Physio-Control, Inc. LIFEPAK 15 MONITOR/DEFIBRILLATOR that was either manufactured with or received an upgrade kit that contained an affected keypad. Terminated |
MKJ | K142430 |
| Nov 19, 2019 | Philips North America, LLC HeartStart XL+ Defibrillator/Monitor, Model 861290 Terminated |
MKJ | K110825 |
| Oct 3, 2019 | Philips North America, LLC HeartStart XL+ Defibrillator/Monitor, Model 861290 Terminated |
MKJ | K110825 |
| Sep 10, 2019 | Philips North America LLC Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED, Model 861304, HSI codeRev: E.03.063 Terminated |
MKJ | K020715 K040904 +1 |
| Sep 10, 2019 | Philips North America LLC Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017 Terminated |
MKJ | K020715 K040904 +1 |
| Jul 16, 2019 | Philips 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 |
MKJ | K063375 |
| Jul 5, 2019 | Philips 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 |
MKJ | K063375 |
| Jun 12, 2019 | ZOLL 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 |
MKJ | None listed |
| Jun 4, 2019 | Cardiac Science Corporation Powerheart G5 Automatic AED Terminated |
MKJ | None listed |
| Feb 26, 2019 | Physio-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 |
MKJ | K142430 |
| Feb 26, 2019 | Physio-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 |
MKJ | K142430 |
| Nov 23, 2018 | Philips North America LLC HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a component of HeartStart MRx Monitor/Defibrillators. Terminated |
MKJ | K051134 |
| Oct 10, 2018 | Philips 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 |
MKJ | None listed |
| Aug 8, 2018 | Philips North America LLC Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758 Terminated |
MKJ | K020715 |
| May 3, 2018 | Philips 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 |
MKJ | K063375 |
| Mar 14, 2018 | Philips Electronics North America Corp. Philips HeartStart (HS1) Onsite/Home AED Terminated |
MKJ | K020715 |
| Mar 14, 2018 | Philips Electronics North America Corp. Philips HeartStart FRx AED. Terminated |
MKJ | K050004 |
| Feb 23, 2018 | ConMed 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 |
MKJ | K002280 |
| Feb 23, 2018 | ConMed 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 |
MKJ | K002280 |
| Feb 23, 2018 | ConMed 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 |
MKJ | K002280 |
| Feb 23, 2018 | ConMed 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 |
MKJ | K002280 |
| Feb 23, 2018 | ConMed 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 |
MKJ | K002280 |
| Feb 8, 2018 | Philips 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 |
MKJ | K031187 K040404 +3 |
| Feb 7, 2018 | Philips 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 |
MKJ | K110825 |
| Jan 11, 2018 | Physio-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 |
MKJ | K130454 |
| Dec 12, 2017 | Physio-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 |
MKJ | K022732 |
| Dec 12, 2017 | Physio-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 |
MKJ | K022732 |
| Sep 12, 2017 | Leonhard 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 |
MKJ | K142803 |
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