BEUDAMED
    12 results · 22ms · Sources: EU EUDAMED, US FDA

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    3M TEGADERM SILVER (AG) MESH

    FDA 510(k)
    FDA Unclassified ·Unknown

    BI-3M NEEDLE-FREE INJECTOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PCCR DIGITAL IMAGING DEVICE

    FDA 510(k)
    FDA Class 2 ·Radiology

    TRULIANT TIB IMP PS INSERT SZ 4 9MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·January 29, 2025

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·August 31, 2023

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·April 11, 2013

    UNIVERSAL DRIVER

    FDA Adverse Event
    Malfunction ·ABBOTT SPINE, INC.·Product code HXX·May 28, 2008

    SIGMA 300 DR

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code DXY·April 13, 2011

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·August 31, 2022

    UNKNOWN BIOLOX DELTA 32MM -4MM HEAD

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code LZO·March 31, 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

    Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

    FDA Enforcement
    Class I ·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024