BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

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    POROCOAT PRODIGY HIP PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SULZER ORTHOPEDICS MS-30 FEMORAL STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ENTEC REFLEX WAND 55, MODEL E4055-01, E4045-01

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

    QUICK SET PARADIGM

    FDA Adverse Event
    Injury ·Product code FPA·May 8, 2024

    PUMP IN STYLE ADVANCED BREAST PUMP BACKPACK

    FDA Adverse Event
    Malfunction ·MEDELA, INC.·Product code HGX·February 11, 2013

    AED PLUS

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·February 3, 2011

    GUIDANT 4.5 MM HEARTSTRING PROXIMAL SEAL

    FDA Adverse Event
    Malfunction ·GUIDANT CARDIAC SURGERY·Product code DXC·February 19, 2008

    HLM TUBING SET

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTM·July 6, 2016

    Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.

    FDA Enforcement
    Class II ·Terminated·Sunrise Medical (US) LLC·December 11, 2013

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: 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

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024