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

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    NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Edge™ Diamond PC014-6.5M Parallel Chamfer

    FDA UDI
    CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172005937·Diamond dental bur, reusable

    MICROZYME THC ENZYME IMMUNOASSAY TEST KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    FOUR TANK DISSOLUTION MODULE

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

    EXT SET, PUR SMALLBORE BIFUSE W/2 CLAVE¿

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·October 3, 2025

    RATCHETING SCREWDRIVER HANDLE

    FDA Adverse Event
    Malfunction ·SYNTHES TUTTLINGEN·Product code OVE·March 31, 2015

    RATCHETING SCREWDRIVER HANDLE

    FDA Adverse Event
    Malfunction ·SYNTHES TUTTLINGEN·Product code OVE·March 31, 2015

    SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM

    FDA Adverse Event
    Malfunction ·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020

    SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM

    FDA Adverse Event
    Malfunction ·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020

    SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM

    FDA Adverse Event
    Malfunction ·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020

    SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM

    FDA Adverse Event
    Malfunction ·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020

    SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM

    FDA Adverse Event
    Malfunction ·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020

    UNSPECIFIED CENTRAL LINE CONNECTOR

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·July 8, 2025

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR·Product code CBK·May 30, 2014

    XPRT W/O PENDANT W/DARTEX

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNM·February 15, 2013

    PRECISION TEST STRIPS

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 20, 2011

    InterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625; InterGard Woven Collagen Coated Vascular prostheses marketed under 510(k} #K970843 and K984294.

    FDA Recall
    Terminated ·Intervascular S.A.S. Zone Industrielle Athelia I La Ciotat Cedex France·Product code DSY·December 9, 2009

    94" (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi) Stopcock, Rotating Luer, Non-DEHP Tubing

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·August 8, 2012