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

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    VARELISA MPO ANCA, MODEL 17648/17696

    FDA 510(k)
    FDA Class 2 ·Immunology

    bioBLOCK® Subtalar Implant System

    FDA UDI
    Ascension Orthopedics, Inc.·10381780280606·Bioblock Combo Driver

    Subtalar MBA Implant System

    FDA UDI
    Smith & Nephew, Inc.·00885556821671·COMBO DRIVER

    LoFric®

    FDA UDI
    Wellspect AB·07392532135293·Single Use Urinary Catheter LoFric Nelaton 6" 10FR

    LoFric®

    FDA UDI
    Wellspect AB·07333387038636·Single Use Urinary Catheter LoFric Nelaton 6" 10FR

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0140400·Driver Shaft, T30 Final Cap Driver

    Universal

    FDA UDI
    Kalitec Direct LLC·B07301K048040·Egg Handle, 1.5 inch Fixed Quarter Square Cannu...

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 29, 2020

    CRYOCARE CARDIAC SURGICAL SYSTEM

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

    FAMILY OF ALTUS MEDICAL MODIFIED COOLGLIDE AESTHETIC LASERS, MODELS COOLGLIDE I, II AND FUTURE MODELS

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

    REMSTAR AUTO M SERIES

    FDA Adverse Event
    Injury ·RESPIRONICS, INC.·Product code BZD·April 14, 2024

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 6, 2011

    RESMED SWIFT

    FDA Adverse Event
    Injury ·RESMED LTD.·Product code BZD·July 18, 2007

    TRACHEOSTOMY TUBE

    FDA Adverse Event
    Malfunction ·SMITHS HEALTHCARE MFG S.A. DE C.V., AVE·Product code JOH·March 31, 2008

    EVOLUT FX DCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·April 10, 2025

    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

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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