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

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    LARYNGEAL SURFACE ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    PROCAD ADD-ON

    FDA 510(k)
    FDA Class 2 ·Dental

    OMNI C ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    COMP RVRS 25MM BSPLT HA+ADPTR

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·March 8, 2021

    TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM

    FDA Adverse Event
    Malfunction ·CODMAN AND SHURTLEFF, INC·Product code HCG·June 15, 2017

    HEARTSTART ONSITE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 26, 2013

    V60 VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code MNT·September 16, 2014

    HUDSON MEDIUM ELONGATED ADULT MASK

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code BYG·April 19, 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

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021