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

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    66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MODIFICATION TO ACRYDERM SILVER ANTIMICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045

    FDA 510(k)
    FDA Unclassified ·Unknown

    NEWDEAL K WIRE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 11, 2021

    INCEPTA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·April 11, 2013

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OZO·September 2, 2014

    CONTAK RENEWAL

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 13, 2011

    SIMULUS FULLY FLEXIBLE ANNULOPLASTY BAND

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·September 30, 2020

    FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/410851; BACT/ALERT FN Plus/410852; BACT/ALERT PF Plus/410853

    FDA Enforcement
    Class II ·Terminated·BioFire Diagnostics, LLC·April 24, 2019

    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