BEUDAMED
    69 results · 23ms · Sources: EU EUDAMED, US FDA

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    AESKULISA TTG A AND AESKULISA TTG G

    FDA 510(k)
    FDA Class 2 ·Immunology

    REPROCESSED TROCARS AND CANNULAS

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

    RADIAL HEAD IMPLANT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·April 9, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 6, 2011

    SELUTE PICOTIP

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008

    INTERSTIM

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·December 2, 2013

    GLIDESHEATH

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DYB·August 7, 2019

    GLIDESHEATH

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DYB·July 7, 2022

    GLIDESHEATH

    FDA Adverse Event
    Death ·TERUMO MEDICAL CORPORATION·Product code DYB·September 6, 2023

    GLIDESHEATH

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DYB·December 1, 2020

    RADIFOCUS INTRODUCER

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DYB·May 19, 2022

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 31, 2013

    RADIFOCUS INTRODUCER

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DYB·January 21, 2022

    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

    GLIDESHEATH

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORPORATION·Product code DYB·September 28, 2023

    RADIFOCUS INTRODUCER

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DYB·June 25, 2020

    RADIFOCUS INTRODUCER

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DYB·June 25, 2020

    RADIFOCUS INTRODUCER

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DYB·June 29, 2020