BEUDAMED
    21 results · 24ms · Sources: EU EUDAMED, US FDA

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    CONSTRUX EXTERNAL FIXATION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Depth gauge

    FDA UDI
    Jeil Medical Corporation·08800089431045·

    Summa Orthopaedics System Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08800089466382·

    PE-210AK SWITCH BOX

    FDA 510(k)
    FDA Class 2 ·Neurology

    EVERGREEN AND MULTIPLE PRIVATE LABELS NON-STERILE POWDERED LATEX PATIENT EXAMINATION GLOVES, WITH PROTEIN LABELING (200

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CHECK-IT

    FDA Adverse Event
    Malfunction ·PFIZER, INC.·Product code QJR·April 30, 2023

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·February 4, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·January 20, 2022

    MONOSYN VIOLET 5/0 (1) 70CM HR17 (M)

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code GAM·December 11, 2019

    ASR UNI FEMORAL IMPL SIZE 51

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 13, 2011

    DUROM US ACETABULAR COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·May 6, 2013

    ASPHERE M SPEC 12/14 40 -2

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·September 23, 2014

    MONOSYN VIOLET 6/0 (0.7) 70CM HR13 (M)

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code GAM·December 11, 2019

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·May 15, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·June 21, 2022

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·March 8, 2018

    PREMILENE 3/0 (2) 75CM DS24 (M)

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code GAW·December 11, 2019

    MONOSYN VIOLET 5/0 (1) 70CM HR17 (M)

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code GAM·December 11, 2019

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015

    BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.

    FDA Enforcement
    Class II ·Ongoing·Biointellisense Inc.·August 21, 2024