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

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    VERSYS FIBER METAL MIDCOAT LOW HEAD CENTER HIP PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VACUETTE SAFETY BLOOD COLLECTION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOG

    FDA 510(k)
    FDA Class 2 ·Dental

    INSORB

    FDA Adverse Event
    Other ·INCISIVE SURGICAL, INC.·Product code GAG·January 18, 2008

    INSORB

    FDA Adverse Event
    Other ·INCISIVE SURGICAL, INC.·Product code GAG·January 18, 2008

    INSORB

    FDA Adverse Event
    Other ·INCISIVE SURGICAL, INC.·Product code GAG·January 18, 2008

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·February 16, 2022

    NEW LIGASURE 5MM

    FDA Adverse Event
    Malfunction ·COVIDIEN LP·Product code GEI·March 29, 2013

    LARGE NEEDLE DRIVER INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC.·Product code GCJ·June 13, 2008

    KCI WOUND VAC

    FDA Adverse Event
    Injury ·KCI·Product code OMP·April 13, 2011

    CERENOVUS ENTERPRISE

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code NJE·January 13, 2025

    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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012