BEUDAMED
    30 results · 23ms · Sources: EU EUDAMED, US FDA

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    Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and Violet Blue)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    LAGWIRE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W

    FDA 510(k)
    FDA Class 2 ·Hematology

    ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LIT·September 12, 2019

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 14, 2014

    ZOLL IVTM QUATTRO CATHETER

    FDA Adverse Event
    Injury ·ZOLL CIRCULATION, INC·Product code NCX·June 7, 2013

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·July 20, 2011

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LIT·January 2, 2019

    ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LIT·February 12, 2019

    ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LIT·March 8, 2019

    ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LIT·February 18, 2019

    ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LIT·January 3, 2020

    ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LIT·January 2, 2020

    ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LIT·July 26, 2019

    ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LIT·November 20, 2019

    ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LIT·November 8, 2019

    DELTAFILL10 3MM X 8CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·November 9, 2022

    GALAXY G3 8MM X 24CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·November 9, 2022