BEUDAMED
    12 results · 28ms · Sources: EU EUDAMED, US FDA

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    AncestryDNA Saliva Collection Kit

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111389740·HUNTER SPLINTER FCP STR 4 1/4"

    NON-CONTACT INFRARED THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TELESENTRY, MODEL TS01

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø42/+0MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·July 21, 2022

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 22, 2014

    TW POWER SUPPLY, US

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code HQO·July 21, 2011

    GYNECARE TVT RETROPUBIC SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·June 27, 2013

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+6MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·December 1, 2023

    18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·July 19, 2017

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·September 30, 2025

    REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ24.5

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·June 20, 2024