BEUDAMED
    6 results · 55ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Enforcement ×

    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 Enforcement
    Class II ·Ongoing·HeartSine Technologies Ltd·October 29, 2025

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

    FDA Enforcement
    Class II ·Ongoing·HeartSine Technologies Ltd·August 6, 2025

    HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with the HeartSine Samaritan Public Access Defibrillator models: 350P/360P/450P/500P

    FDA Enforcement
    Class II ·Ongoing·HeartSine Technologies Ltd·July 19, 2023

    Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-automatic defibrillator with CPR Advisor

    FDA Enforcement
    Class II ·Ongoing·HeartSine Technologies Ltd·March 15, 2023

    HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P

    FDA Enforcement
    Class II ·Ongoing·HeartSine Technologies Ltd·May 22, 2024

    HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/350-UNIT-US-10, 350-STR-US-10, 350-STR-UK-10; SAM 360P/360-STR-JA-10, 360-STR-DE-10, 360-STR-UK-10; SAM 450P/450-UNIT-US-08, ; SAM 500P/500-BAS-UK-10

    FDA Enforcement
    Class II ·Ongoing·HeartSine Technologies Ltd·February 21, 2024