BEUDAMED
    15 results · 22ms · Sources: EU EUDAMED, US FDA

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    Anterior Spine Truss System (STS) Interbody Fusion Device

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RANGE SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ARTHROCARE SPINEWANDS

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

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 14, 2014

    GOBED II

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·June 14, 2013

    WATER RESISTANT EXTERNAL PADDLES

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·June 22, 2011

    POD PACKING COIL

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·November 8, 2017

    BD INTIMA-II CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·September 22, 2020

    HEMOSIL ACUSTAR HIT-IGG(PF4-H)

    FDA Adverse Event
    Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025

    HEMOSIL ACUSTAR HIT-IGG(PF4-H)

    FDA Adverse Event
    Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025

    POD PACKING COIL

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·October 23, 2017

    HEMOSIL ACUSTAR HIT-IGG(PF4-H)

    FDA Adverse Event
    Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code LCO·June 6, 2025

    HEMOSIL ACUSTAR HIT-IGG (PF4-H)

    FDA Adverse Event
    Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code LCO·April 8, 2025

    HEMOSIL ACUSTAR HIT-IGG(PF4-H)

    FDA Adverse Event
    Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025

    Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026