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

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    Stryker iVAS 13g Bone Biopsy Kit

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

    DAVINCI XI STAPLER 45

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL INC·Product code GDW·July 3, 2018

    HEARTWAY POWER CHAIR, P23

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    LDR SPINE ROI-A INTERBODY FUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·December 15, 2020

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·October 15, 2014

    PROMUS ELEMENT? PLUS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·June 20, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011

    OPTILENE 6/0 (0,7) 75CM 2XDRC13 CV2 RCP

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAW·December 9, 2025

    OPTILENE 7/0 (0,5) 60CM 2XDRC8 CV2 RCP

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAW·December 9, 2025

    STEALTHSTATION¿ S8 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·December 16, 2021

    STEALTH S8 PREMIUM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·May 27, 2020

    SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR).

    FDA Enforcement
    Class II ·Terminated·Shimadzu Medical Systems Usa Com·March 27, 2019

    AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US

    FDA Enforcement
    Class II ·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022

    Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025