BEUDAMED
    16 results · 19ms · Sources: EU EUDAMED, US FDA

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    AUDIOMETER, DIAG., ADVANCED, MA-22

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    OMNIARCH®

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K77055611·OMNIARCH® EURO 022 UL/5-5 CS HK

    OMNIARCH®

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K77055221·OMNIARCH® Base Rx 022 UL/5-5 CS-BC HK

    OMNIARCH®

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K77055621·OMNIARCH® EURO 022 UL/5-5 CS-BC HK

    OMNIARCH®

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K77055131·OMNIARCH® Base Rx 018 UL/5-5 CS HK

    OMNIARCH®

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K77055121·OMNIARCH® Base Rx 018 UL/5-5 CS-BC HK

    OMNIARCH®

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K77055281·OMNIARCH® CETLIN® 022 UL/5-5 CS HK

    OMNIARCH®

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K77055231·OMNIARCH® Base Rx 022 UL/5-5 CS HK

    OMNIARCH®

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K77055301·OMNIARCH® BI-DIMENSIONAL® UL/5-5 CS HK

    Altus Spine Interbody Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PRINTER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ACCU-CHEK AVIVA

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·October 25, 2007

    HEARTSTART ONSITE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 18, 2014

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·October 3, 2012

    Site~Rite 8 Ultrasound Systems-intended for diagnostic ultrasound imaging of the human body. Site~Rite 8 Ultrasound System, Catalog No.9770500 Refurbished, Site~Rite¿ 8 System, Catalog No.9770500R Site~Rite 8 Ultrasound System, Catalog No.9770501 Refurbished Site~Rite¿ 8 System,Catalog No.9770501R Site~Rite 8 Ultrasound System, Catalog No. 9770550 Site~Rite 8 Ultrasound System, Catalog No. 9770552 Site~Rite 8 Ultrasound System, Catalog No. 9770553 Site~Rite 8 Ultrasound System, Catalog No. 9770554 Site~Rite 8 Ultrasound System, Catalog No. 9770555 Site~Rite 8 Ultrasound System Console with Connector, Catalog No.: 9770600 Site~Rite 8 Ultrasound System Console with Connector, Refurbished, Catalog No: 9770600X Site~Rite 8 Ultrasound System Console with Connector (Remanufactured) Catalog No: 9770600Y

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·December 4, 2019

    Site~Rite 8 Ultrasound Systems-intended for diagnostic ultrasound imaging of the human body. Site~Rite 8 Ultrasound System, Catalog No.9770500 Refurbished, Site~Rite 8 System, Catalog No.9770500R Site~Rite 8 Ultrasound System, Catalog No.9770501 Refurbished Site~Rite 8 System,Catalog No.9770501R Site~Rite 8 Ultrasound System, Catalog No. 9770550 Site~Rite 8 Ultrasound System, Catalog No. 9770552 Site~Rite 8 Ultrasound System, Catalog No. 9770553 Site~Rite 8 Ultrasound System, Catalog No. 9770554 Site~Rite 8 Ultrasound System, Catalog No. 9770555 Site~Rite 8 Ultrasound System Console with Connector, Catalog No.: 9770600 Site~Rite 8 Ultrasound System Console with Connector, Refurbished, Catalog No: 9770600X Site~Rite 8 Ultrasound System Console with Connector (Remanufactured) Catalog No: 9770600Y

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code IYO·November 4, 2019