BEUDAMED
    30 results · 29ms · Sources: EU EUDAMED, US FDA

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    ElastiMed SACS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517570413·CoRoent Ant TLIF Ti, 13x12x30mm 0°

    NA

    FDA UDI
    Medos International Sàrl·10886705011117·ACL Disposables Kit 18 Inches Bayonet Point Pas...

    VK Couture

    FDA UDI
    Diversified Products, Inc.·00842894182284·

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776202323·Barraquer Iris Spatula Round Handle

    Ophthalmic Spatula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668102367·BARRAQUER IRIS SPATULA 0.5MM

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702777772·ELVAREX 2/KNEE HIGH/SLANT-OPEN TOE-ELEPHANTIASI...

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04059993122059·ELVAREX 4/THIGH HIGH/PROFILE, OPEN TOE, KNEE F...

    ACCOLADE-J HIP STEM SERIES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EPIX ELECTROSURGICAL PROBE SPATULA TIP, EPIX ELECTROSURGICAL PROBE L-HOOK TIP, EPIX ELECTROSURGICAL PROBE J-HOOK TIP, RE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·March 22, 2024

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·February 17, 2023

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 6, 2014

    UNKNOWN DEPUY ASR HEAD

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD.·Product code KXA·August 18, 2011

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL SIZER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DTI·November 6, 2008

    ITREL 4

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 13, 2013

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Enforcement
    Class II ·Ongoing·Abbott Point Of Care Inc.·September 24, 2025

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Recall
    Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

    VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI Number 10758750004294 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine kinase MB (CK-MB) activity in serum which used to be ordered to detect Myocardial Infarction.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·May 20, 2020

    ACL ACC DISPOSABLES KIT *EA

    FDA Adverse Event
    Injury ·DEPUY MITEK LLC US·Product code LXH·February 4, 2019