BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    TRAUMAFIX (TM) EXTERNAL FIXATOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DUAL LUMEN 5 FR PERIP CENT VEN CATH W/GROSHONG VAL

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TERUMO(R) ARTERIAL AND VENOUS BLOOD LINE SET

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PSO KNEE BONE SUBSTITUTION

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code KRO·April 22, 2022

    SINGLE USE ASPIRATION NEEDLE NA-U401SX

    FDA Adverse Event
    Injury ·AOMORI OLYMPUS CO., LTD.·Product code FCG·August 3, 2023

    PSO KNEE BONE SUBSTITUTION

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code KRO·July 18, 2019

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·January 14, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 3, 2010

    UNIFY ASSURA DR CRT-D

    FDA Adverse Event
    Death ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·July 3, 2014

    UNKNOWN HEAD

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·February 16, 2018

    SINGLE USE ASPIRATION NEEDLE NA-U401SX

    FDA Adverse Event
    Injury ·AOMORI OLYMPUS CO., LTD.·Product code FCG·August 3, 2023

    PKG, SPRING HANDLE, P/N 0250080237. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits with Mode Numbers: 989603014351 & 989603014352.

    FDA Enforcement
    Class I ·Ongoing·Philips North America Llc·July 3, 2024