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

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    VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION PROCESSES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100331601·IN-OVATION® C Roncone 018 UL/ 3-3 CS HK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100331101·IN-OVATION® C Base Rx 018 UL/3-3 CS HK

    QWH-149 WRIST ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    LYMPHA PRESS PLUS DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·May 9, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 19, 2014

    2800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 17, 2011

    HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC·Product code DSQ·August 15, 2017

    SURGIGUIDE - 2 IMPLANTS

    FDA Adverse Event
    Injury ·DENTSPLY IMPLANTS N.V.·Product code NDP·July 19, 2022

    M6-C

    FDA Adverse Event
    Injury ·SPINAL KINETICS LLC·Product code MJO·September 4, 2019

    LOCKING PROXIMAL FEMORAL PLATE, 150 DEGREE, 4.5MM, 5-HOLE

    FDA Adverse Event
    Injury ·ORTHOPEDIATRICS, INC·Product code HRS·May 10, 2019

    Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.

    FDA Enforcement
    Class III ·Terminated·Illumina Inc·December 31, 2014

    M6-C

    FDA Adverse Event
    Injury ·SPINAL KINETICS LLC·Product code MJO·June 5, 2019

    INVICTUS SPINAL FIXATION SYSTEM

    FDA Adverse Event
    Malfunction ·ALPHATEC SPINE, INC.·Product code OLO·May 6, 2026

    CAPIOX RX25 OXYGENATOR WEST

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code DTZ·September 13, 2019

    M6-C

    FDA Adverse Event
    Injury ·SPINAL KINETICS LLC·Product code MJO·December 24, 2019

    MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688N, QTY 100, Microtek Medical, Inc., Columbus, MS 39702.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·February 19, 2014

    M6-C

    FDA Adverse Event
    Injury ·SPINAL KINETICS LLC·Product code MJO·April 13, 2021

    TRESTLE LUXE ANTERIOR CERVICAL PLATING SYSTEM

    FDA Adverse Event
    Malfunction ·ALPHATEC SPINE INC·Product code KWQ·June 22, 2021