BEUDAMED
    19 results · 18ms · Sources: EU EUDAMED, US FDA

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    CPK ISOENZYME CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MEGA PLUS MIS SPINE SYSTEM

    FDA UDI
    BK MEDITECH CO.,LTD.·08809763496165·MIS Fenestrated Screw, Ø10.5 x 55mm, Ø6.0mm Rod

    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

    INHANCE SHOULDER SYSTEM

    FDA UDI
    DEPUY (IRELAND)·10603295551805·INHANCE SHOULDER SYSTEM READY- SET GO REVERSE K...

    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

    U Deliver Bolink ENFit Enteral Feeding Sets

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

    ORTHOPRO STEINMAN PINS AND KIRSCHNER WIRES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HEARTSTART ONSITE

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

    SOFT TOUCH II

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

    GYNECARE MORCELLEX* TISSUE MORCELLATOR

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code HET·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

    ACCOLADE SR SL MRI (Model L310)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025