BEUDAMED
    16 results · 21ms · Sources: EU EUDAMED, US FDA

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    NASOPORE-FD

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    ICU Medical

    FDA UDI
    ICU MEDICAL, INC.·00840619046477·Central Venous Catheter, Heparin Coated, 3 Lume...

    K2M General Instruments

    FDA UDI
    VB Spine LLC·10888857581180·Split Tube Retractor Ø16x50 mm

    VIABIL BILIARY ENDOPROSTHESIS

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

    OPTIBOND XTR

    FDA 510(k)
    FDA Class 2 ·Dental

    TIBIAL INSERT FIXED SPHERE FLEX #5/13 MM L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 16, 2018

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013

    IN TOUCH ZU

    FDA Adverse Event
    Malfunction ·FLEXTRONICS EMS CANADA·Product code FNL·June 1, 2011

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·September 3, 2008

    GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 5 LEFT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 6, 2017

    Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41414-23

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·May 20, 2020

    Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41414-23

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code DQE·January 2, 2020

    KINETRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MRU·August 28, 2013

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MRU·August 28, 2013

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MRU·August 28, 2013

    KINETRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MRU·August 28, 2013