BEUDAMED
    9 results · 28ms · Sources: EU EUDAMED, US FDA

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    IL THEOPHYLLINE ASSAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756372473·SOFT TISSUE PACK

    UNIQUE AMBULATORY EEG

    FDA 510(k)
    FDA Class 2 ·Neurology

    TIGER SYRINGES AND NEEDLES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    RESTORE ADVANCED RECHARGEABLE

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·November 22, 2010

    RESTORE SENSOR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 2, 2014

    TOTALCARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·December 4, 2012

    Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015