BEUDAMED
    20 results · 29ms · Sources: EU EUDAMED, US FDA

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    MODEL PMT850

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    E300 360 Delivery System

    FDA UDI
    Engle Dental Systems, LLC·00850043433231·Chair mounted left / right convertible delivery...

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496070931·MISS RELAX 140 OPEN TOE, SIZE S, CAMEL, GRADUAT...

    AMS SACRAL COLPOPEXY SLING, MODEL 72403501

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

    AU5 ULTRASOUND IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    PROTECTA XT DR

    FDA Adverse Event
    Death ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·April 22, 2013

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·April 27, 2011

    ZENITH AAA LEG EXTENSION DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·COOK, INC.·Product code MIH·July 3, 2008

    TRIFORCE¿ PERIPHERAL CROSSING SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·February 4, 2020

    2CM PERIPHERAL CUTTING BALLOON

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LIT·December 4, 2019

    BIODESIGN URETHRAL SLING

    FDA Adverse Event
    Injury ·COOK BIOTECH·Product code FTM·July 29, 2013

    TRIFORCE¿ PERIPHERAL CROSSING SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·January 2, 2020

    TRIFORCE¿ PERIPHERAL CROSSING SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·February 4, 2020

    TRIFORCE¿ PERIPHERAL CROSSING SET

    FDA Adverse Event
    Injury ·COOK INC·Product code KRA·January 2, 2020

    2CM PERIPHERAL CUTTING BALLOON

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LIT·October 7, 2019

    2CM PERIPHERAL CUTTING BALLOON

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LIT·August 19, 2019

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022