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    ANTIBODY TO VARICELLA-ZOSTER VIRUS

    FDA 510(k)
    FDA Class 2 ·Hematology

    ACUMED

    FDA UDI
    Acumed LLC·10806378044762·Hand & Wrist Implant Platter

    RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BIOMOVE 5000 SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    RESTORE SENSOR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 8, 2014

    ARTICULEZE M HEAD 36MM +1.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·October 23, 2012

    OT PING ENHANCED METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 28, 2015

    HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak

    FDA Recall
    Terminated ·Physio-Control, Inc.·Product code MKJ·January 13, 2022

    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 patented Shock Advisory System. This software algorithm analyzes the patient s electrocardiographic (ECG) rhythm and indicates whether it detects a shockable rhythm. The LIFEPAK 500 AED requires operator interaction to defibrillate the patient.

    FDA Recall
    Terminated ·Physio-Control, Inc.·Product code MKJ·March 20, 2020

    HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J

    FDA Recall
    Open, Classified ·HeartSine Technologies Ltd 207 Airport Road West Belfast United Kingdom·Product code MKJ·September 18, 2025

    LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.

    FDA Recall
    Open, Classified ·Jolife AB Scheelevagen 17 Ideon Science Park Lund Sweden·Product code DRM·May 21, 2025

    HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan PAD (Public Access Defibrillator)

    FDA Recall
    Open, Classified ·HeartSine Technologies Ltd 207 Airport Road West Belfast United Kingdom·Product code MKJ·June 30, 2025

    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 Usage: intended to be used by personnel who are trained on the device operation and in basic life support or other physician-authorized emergency medical response system.

    FDA Recall
    Terminated ·Physio-Control, Inc.·Product code MKJ·April 24, 2020

    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 CR Plus/EXPRESS defibrillator - Product Usage: intended to be used by personnel who are trained on the device operation and in basic life support or other physician-authorized emergency medical response system.

    FDA Recall
    Terminated ·Physio-Control, Inc.·Product code MKJ·April 24, 2020

    AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098

    FDA Recall
    Open, Classified ·Physio-Control, Inc.·Product code MKJ·November 6, 2023

    LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-001935, 99577-001964, 99577-001955, 99577-001956, 99577-001588, 99577-001958, 99577-001950, 99577-001962, 99577-002178, 99577-001372, 99577-001938, 99577-000045; LIFEPAK 1000, REF: 99425-000025, 99425-000023, 99425-000096; LIFEPAK 35, REF: 99335-000013, 99335-000031; LIFEPAK 20e, REF: 99507-000122

    FDA Recall
    Open, Classified ·Physio-Control, Inc.·Product code MKJ·April 13, 2026

    LIFEPAK 15 MONITOR/DEFIBRILLATOR service kits

    FDA Recall
    Terminated ·Physio-Control, Inc.·Product code MKJ·December 20, 2019

    Power-PRO 2- A powered ambulance cot that consists of a platform, including a mattress, mounted on a wheeled, retractable X-frame that is designed to support and transport a maximum weight of 700 lb (318 kg). Model Number: 6507

    FDA Recall
    Open, Classified ·Stryker Medical Division of Stryker Corporation·Product code FPO·May 24, 2023

    STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Synchronized cardioversion is indicated for the treatment of atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, supraventricular tachycardia, and in relatively stable patients, ventricular tachycardia.

    FDA Recall
    Open, Classified ·Physio-Control, Inc.·Product code LDD·August 9, 2024

    LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000025 / 885074698953 331706400001 / 99425-000025 / 885074698953 LIFEPAK 1000: The defibrillator is to be used in AED mode only on patients who are in cardiopulmonary arrest. The patient must be unresponsive, not breathing normally, and showing no signs of circulation. ECG monitoring is for use on conscious and unconscious patients of all ages for the purpose of ECG rhythm recognition and heart rate monitoring.

    FDA Recall
    Open, Classified ·Physio-Control, Inc.·Product code MKJ·July 22, 2025