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

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    LV Liberty Vision Model 1 90Yttrium Brachytherapy Source

    FDA 510(k)
    FDA Class 2 ·Radiology

    SAIPH

    FDA UDI
    MATORTHO LTD·05055455506176·SAIPH Fixed Tibial Tray Cemented Size C

    AAP LOQTEQ PROXIMAL LATERAL TIBIA PLATE 4.5 SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EUDERMIC MP LATEX EXAMINATION GLOVE-BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) W/ A PROTEIN CONTENT LABEL CLAIM

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SAIPH KNEE

    FDA Adverse Event
    Malfunction ·MATORTHO LIMITED·Product code JWH·June 13, 2019

    SAIPH KNEE

    FDA Adverse Event
    Malfunction ·MATORTHO·Product code JWH·October 9, 2018

    QUICKFLEX MICRO LV LEAD

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CRMD·Product code NIK·January 13, 2014

    HALO PKS CUTTING FORCEPS

    FDA Adverse Event
    Malfunction ·GYRUS MEDICAL, INC.·Product code GEI·July 14, 2011

    2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·June 27, 2013

    LASSOSTARNAV,10P,15MM DIA LOOP

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code DRF·February 22, 2023

    LASSOSTAR CATHETER

    FDA Adverse Event
    Death ·BIOSENSE WEBSTER INC.·Product code DRF·December 30, 2020

    LASSOSTAR NAV CIRCULAR MAPPING CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DRF·November 23, 2022

    X-COATED SMALL PATIENT PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·July 4, 2012