BEUDAMED
    17 results · 20ms · Sources: EU EUDAMED, US FDA

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    DISCOVERY-MOSAIC TOTAL HUMERUS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IBP ELB INT. ULNA LRG RGT LNG STM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JDC·June 24, 2016

    ZEUS-P

    FDA UDI
    SPINAL ELEMENTS, INC.·00840606160827·FLAT PADDLE DISTRACTOR, 5MM

    BD LUER-LOK¿ TIP DISPOSABLE SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON DE MEXICO·Product code FMF·August 5, 2021

    KFA-127 KNEE, FOOT AND ANKLE ARRAY

    FDA 510(k)
    FDA Class 2 ·Radiology

    AUROFLUID PLUS

    FDA 510(k)
    FDA Class 2 ·Dental

    BD LUER-LOK¿ TIP DISPOSABLE SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON DE MEXICO·Product code FMF·August 18, 2021

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 9, 2013

    STENOSCOP

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD·Product code JAA·March 28, 2011

    FINELINE II

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008

    BD LUER-LOK TIP DISPOSABLE SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·August 5, 2021

    BD VACUTAINER® CAT (CLOT ACTIVATOR TUBE) PLUS BLOOD COLLECTION TUBE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·July 3, 2018

    PKG, 3MM PEEK MULTI-FUNCTION HANDLE, P/N 0250282046 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    B12 Reagent (6C09-20 and 6C09-25) for use with the ARCHITECT i2000 and i2000SR Analyzers, List numbers 8C89-01 and 3M74-01. The reagent is manufactured by Abbott Laboratories, Abbott Park, IL. The ARCHITECT instrument is manufactured by Abbott Laboratories, Irving Texas

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code LID·December 14, 2001

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018