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

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    SPO2.COM OXIMETRY SENSORS, MULTIPLE MODELS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Baltic Denture System BDLoad

    FDA UDI
    Merz Dental GmbH·D7091033298·Baltic Denture System BDLoad BDLoad Mn6 PLSEbi...

    PN RELION 32G X 4MM 3B TW 50CT

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FMI·January 28, 2022

    MO-202U THREE-AXIS JOYSTICK HYDRAULIC MICROMANIPULATOR

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

    HEMCON BANDAGE

    FDA 510(k)
    FDA Unclassified ·Unknown

    RAD-5 PULSE OXIMETER

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·July 13, 2018

    HOURGLASS

    FDA Adverse Event
    Injury ·MEDTRONIC·Product code MQP·June 16, 2014

    TOTALCARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·March 1, 2013

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS LLC (PR)·Product code NIQ·March 30, 2011

    REZOOM

    FDA Adverse Event
    Injury ·ADVANCED MEDICAL OPTICS·Product code HQL·April 22, 2008

    POLYMOBIL PLUS

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE GMBH·Product code IZL·July 27, 2023

    RELION PEN NEEDLES 4MM X 32 GAUGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FMI·July 13, 2022

    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

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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