BEUDAMED
    15 results · 19ms · Sources: EU EUDAMED, US FDA

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    VALVE, AMBU PEEP

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MR 5000 Series

    FDA UDI
    Philips Medical Systems Nederland B.V.·00884838112841·Philips innovative MR 5300 magnetic resonance i...

    Novo Surgical

    FDA UDI
    NOVO SURGICAL, INC.·G586E7821520·joseph nasal knife, double-edged, 6" (15.2 cm),...

    FACELIFT SCISSORS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    CENTRAL MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RECIPROCATING SAW ATTACHMENT

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code GFA·April 30, 2014

    ALARIS PC UNIT

    FDA Adverse Event
    Injury ·CAREFUSION CORP.·Product code FRN·October 3, 2012

    HEARTSINE SAMARITAN 300P AND PAD PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·April 24, 2015

    Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152;

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·May 13, 2025

    MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·June 30, 2025

    Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152;

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 28, 2025

    MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;

    FDA Enforcement
    Class II ·Ongoing·Philips North America·August 6, 2025

    MR 5300- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782152 (2) 782110

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·May 3, 2024

    MR 5300- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782152 (2) 782110

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 29, 2024

    Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781350

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 29, 2024