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

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    SYNTHESIS PH.I.S.I.O. ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARETERIAL FILTER AND HARDSHELL VENOUS/CARIOTOMY RESERVOI

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FR CLERMONT FERRAND

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·October 3, 2012

    MERCY HSP PITTSBURGH PA 1

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DWE·May 7, 2009

    HCSG/HENDRICK MED/ABLNE TX 1

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA, INC.·Product code DWE·February 16, 2010

    DIDECO COMPACTFLO EVO

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·January 16, 2013

    DIDECO COMPACTFLO EVO

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code KFM·December 13, 2012

    DIDECO COMPACTFLO EVO

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·October 18, 2012

    ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    BIOTEQUE VAGINAL DILATOR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    COMPREHENSIVE INSTRUMENTATION

    FDA Adverse Event
    Malfunction ·BIOMET ORTHOPEDICS, LLC·Product code HTW·July 26, 2019

    ATTUNE FB TIB BASE SZ 3 CEM

    FDA Adverse Event
    Injury ·DEPUY (IRELAND) 9616671·Product code JWH·April 23, 2013

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·May 1, 2011

    LASERDISH

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·July 11, 2008

    BD MICRO-FINE ULTRA¿ INSULIN PEN NEEDLE

    FDA Adverse Event
    Injury ·BECTON DICKINSON AND CO.·Product code FMI·August 13, 2015

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022

    Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636; CD1277-36Q/100048374, 100048394, 100060198, 100098497, 100116268, 100116345; CD1293-36Q/100057838; CD1309-36/100057717; CD1309-36Q/100057718; CD1311-36/100057802, 100060153; CD1311-36Q/100057803, 100060174, 100116264; CD1377-36/100078796, 100079180, 100096847; CD1377-36C/100078612, 100079197, 100079368, 100116120, 100116407, 100116447; CD1377-36Q/100078747, 100079210, 100096848, 100116385, 100116423, 100116427; CD1377-36QC/100078602, 100079199, 100079229, 100116398, 100116409, 100116466,100116485, 100127151, 100127152, 100127153; CD1393-36C/100116461; CD1393-36QC/100080656, 100116339; CD1409-36Q/100080251; CD1411-36C/100080197, 100080232, 100116411, 100116481; CD1411-36Q/100080244, 100080245, 100116338, 100116464; CD1411-36QC/100116337; CD2275-36/100116355; CD2275-36Q/100116349; CD2277-36/100048359, 100048402, 100116206, 100116207; CD2277-36Q/100048377, 100048404,100060190, 100098661, 100116342, 100116350; CD2293-36/100057765; CD2293-36Q/100057766; CD2309-36/100057804; CD2309-36Q/100057763; CD2311-36/100057679, 100060100; CD2311-36Q/100057835, 100060161, 100116351; CD2377-36/100078811, 100079226, 100096774; CD2377-36C/100078601,100079225, 100079304, 100116405, 100116424, 100116484; CD2377-36Q/100078812,100079208, 100096838, 100116406, 100116414, 100116437; CD2377-36QC/100078579, 100079176, 100079352, 100116413, 100116422, 100116436, 100116482, 100127100, 100127154, 100127181; CD2393-36C/100080653, 100116416; CD2393-36QC/100080655, 100116451; CD2409-36C/100079997; CD2409-36Q/100080149; CD2411-36C/100079986, 100080104, 100116118, 100116444; CD2411-36Q/100080180, 100080230, 100116370, 100116420

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