BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

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    ENDOMETRIAL SAMPLER

    FDA 510(k)
    FDA Class 1 ·Dental

    MASIMO LNCS/M-LNCS OXIMETRY SENSORS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS; KENZ ECG 110 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS WITH EC

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 27, 2022

    LNCS DC-I

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·March 11, 2017

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND·Product code CBK·May 7, 2014

    SIG TKA GDE/MDL SET 03-05

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·January 8, 2013

    ACRYSOF

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·November 12, 2010

    ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE

    FDA Adverse Event
    Injury ·COOK INC·Product code DQX·January 26, 2018

    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

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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