BEUDAMED
    16 results · 35ms · Sources: EU EUDAMED, US FDA

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    PRO-KUP

    FDA 510(k)
    FDA Class 1 ·Dental

    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

    TROCHANTERIC NAIL KIT, TI GAMMA3 11X180MM X 125

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 1, 2012

    IRRIGATION CATHETER

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

    BRAINSUITE NET

    FDA 510(k)
    FDA Class 2 ·Neurology

    HEARTSTART HOME

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

    ACCU-CHEK COMFORT CURVE TEST STRIPS

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

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 3, 2012

    Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 8, 2017