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

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    GX Navigation Instrument System

    FDA 510(k)
    FDA Class 2 ·Neurology

    Syntec Osteo-plate and screw Fixation

    FDA UDI
    SYNTEC SCIENTIFIC CORPORATION·04712782853977·Cortex Screw Self-Tappingφ2.7 x L36mm

    NA

    FDA UDI
    Synthes GmbH·10886982144843·2.7MM CORTEX SCREW SELF-TAPPING 36MM

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113417·IMPLANT KNIFE 5.2MM (BX/5)

    MEDIA FOR GAMETE PREPARATION AND EMBRYO CULTURE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    STEPHENS DISPOSABLE SPECULUM

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    ACCU-CHEK ® SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LZG·October 27, 2014

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY·Product code HQL·August 11, 2011

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS·Product code LYJ·July 2, 2013

    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

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021