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

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    PK NEEDLE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Gyrus ACMI

    FDA UDI
    Gyrus ACMI, LLC·00821925015814·RICHARDS FLUOROPLASTICS BUCKET HANDLE PROSTHESI...

    GE DATEX-OHMEDA AISYS CARESTATION

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·June 24, 2022

    AISYS

    FDA Adverse Event
    Malfunction ·DATEX-OHMEDA, INC.·Product code BSZ·January 18, 2016

    AISYS

    FDA Adverse Event
    Malfunction ·DATEX-OHMEDA, INC.·Product code BSZ·January 15, 2016

    FREESTYLE LIBRE 2

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code QLG·May 19, 2026

    VITROS 5,1 FS CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·February 22, 2019

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·April 6, 2012

    TIBIAL NAIL, LEFT

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code JDS·October 5, 2014

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·June 3, 2013

    PENUMBRA COIL 400

    FDA Adverse Event
    Malfunction ·PENUMBRA INC.·Product code HCG·May 26, 2011

    BD VENFLON ¿ PRO SAFETY IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·August 1, 2018

    PKG, BIOPSY FORCEPS, SPOON W/PIN, P/N 0250080291. 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

    PKG, BIOPSY FORCEPS, SPOON W/PIN, P/N 0250080291. 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