BEUDAMED
    15 results · 28ms · Sources: EU EUDAMED, US FDA

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    XENON-100 SCB LIGHT SOURCE, MODEL 20132620

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

    DUR-8, MODELS DUR-8

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

    COOLBLU CURING LIGHT

    FDA 510(k)
    FDA Class 2 ·Dental

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 11, 2024

    PORTEX CONTINUOUS EPIDURAL TRAY

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD, INC·Product code CAZ·April 22, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·May 10, 2011

    HARMONIC ACE 36 CM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code LFL·July 25, 2008

    CORIN METAFIX HIP STEM

    FDA Adverse Event
    Injury ·CORIN MEDICAL·Product code LZO·September 6, 2022

    COAGUCHEK XS SYSTEM

    FDA Adverse Event
    Injury ·ROCHE DIAGNOSTICS·Product code GJS·August 10, 2020

    HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO

    FDA Enforcement
    Class II ·Terminated·Terumo BCT, Inc.·November 22, 2017

    HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO

    FDA Enforcement
    Class II ·Terminated·Terumo BCT, Inc.·November 22, 2017

    HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO

    FDA Recall
    Terminated ·Terumo BCT, Inc.·Product code JQC·October 20, 2017

    HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO

    FDA Recall
    Terminated ·Terumo BCT, Inc.·Product code JQC·October 20, 2017

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015