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

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    FDA 510(k)
    FDA Class 2 ·Orthopedic

    10600 DEFLECTABLE CATHETER SYSTEM, MODEL 10600

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OTRES TOOTHBRUSH SANITIZER MODEL TB100W

    FDA 510(k)
    FDA Class 1 ·Dental

    BIOLOX OPTION, HEAD, S, 44/-3.0, TAPER 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code LZO·December 12, 2018

    PROMUS ELEMENT¿ PLUS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·April 23, 2013

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    FDA Adverse Event
    Malfunction ·HOSPIRA·Product code KPE·April 20, 2011

    DURATA STS OPTIM ACTIVE FIXATION LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008

    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

    Alcon Custom Ophthalmic Surgical Procedure Packs

    FDA Enforcement
    Class II ·Terminated·Alcon Research, LLC·April 7, 2021