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

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    ZIROX

    FDA 510(k)
    FDA Class 2 ·Dental

    QUALITROL DHP IMMUNOASSAY CONTROL, LEVELS 1,2, AND 3

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SURGASSIST FLEXSHAFT 2, MODEL FS2 14

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

    CAPSUREFIX

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·April 10, 2013

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·May 22, 2008

    ICEMAN THERAPY UNIT

    FDA Adverse Event
    Injury ·DJ ORTHOPEDICS DE MEXICO·Product code ILO·April 6, 2011

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. 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