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

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    TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Zavation

    FDA UDI
    Zavation LLC·00842166176522·Slim Rod Inserter

    Fine osteotomy HA 4.5 Cortical Bone Screw - L52mm

    FDA UDI
    Laboratoires Bodycad Inc·00688346002829·Button Head Locking HA 4.5 Cortical Self Tappin...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523106271·Porous Acetabular Cup System - Hemispherical Sh...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523166572·Initia T3 Acetabular Hemispherical Shell, Multi...

    980 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code CBK·December 14, 2016

    OMNI III PATIENT MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CARESTART HCG ONE-STEP PREGNANCY TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HAHN TAPERED IMPLANT 4.3 X 8 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·October 10, 2023

    HAHN TAPERED IMPLANT Ø4.3 X 8 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·October 15, 2025

    HAHN TAPERED IMPLANT Ø4.3 X 8 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·April 24, 2024

    HAHN TAPERED IMPLANT Ø4.3 X 8 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 7, 2025

    HAHN TAPERED IMPLANT Ø4.3 X 8 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·October 5, 2023

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 1, 2014

    ENDO STITCH 10MM SUTURING DEVICE

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY US SURGICAL·Product code KOG·May 21, 2013

    PACEART SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DPS·June 16, 2011

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

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

    The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

    FDA Enforcement
    Class II ·Ongoing·Abbott Medical·January 1, 2025