BEUDAMED
    19 results · 28ms · Sources: EU EUDAMED, US FDA

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    ALPHA DX SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890105620·Zirlux UCLA Plastic Abut Eng

    Endo Carry-on Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964151033·Endo Carry-on Procedure Kit contains Intercept ...

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0105020·Implant Inserter, 14-16mm, Sleeved

    SYNOVO HIP COMPONENTS

    FDA UDI
    Synovo Production·00814193025845·HIP ACETABULAR FIXATION CUP - 62 MM 5 HOLE

    B-P TOTAL HIP SYSTEM

    FDA UDI
    ENDOTEC, INC.·00814193022653·B-P HIP ACETABULAR FIXATION CUP W/BIOCOAT & W/U...

    NEURO SCAN MEDICAL SYSTEMS A4000

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    STYROFOAM CUTTERS FOR BLOCK CASTING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    STREP A RAPID TEST STRIP (THROAT SWAB)

    FDA Adverse Event
    Death ·ABON BIOPHARM (HANGZHOU) CO., LTD.·Product code GTY·March 25, 2024

    ACETABULAR FIXATION CUP, (xx)MM, 5 HOLE, Ti-6AI-4V ELI TiN CERAMIC W/PLASMA SPRAY, STERILEEO, Reference Numbers: 01-01-0554 01-01-0556 01-01-0558 01-01-0560 01-01-0562 01-01-0564 01-01-0566

    FDA Enforcement
    Class II ·Ongoing·Synovo Production·April 17, 2024

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·March 15, 2013

    ARCTIC FRONT CARDIAC CRYOABLATION CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC CRYOCATH LP·Product code OAE·March 1, 2011

    ATLAS + HF CRT-D

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·March 10, 2008

    LATITUDE ELBOW ANATOMIC HUMERAL SPOOL SZ PETIT+ SIDE GAUCHE

    FDA Adverse Event
    Injury ·TORNIER INC·Product code JDC·May 7, 2024

    BACFIX ROD, UNKNOWN

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code HSB·January 16, 2020

    Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.

    FDA Enforcement
    Class II ·Completed·Accuray Incorporated·September 6, 2023

    ACETABULAR FIXATION CUP, (xx)MM, 5 HOLE, Ti-6AI-4V ELI TiN CERAMIC W/PLASMA SPRAY, STERILEEO, Reference Numbers: 01-01-0554 01-01-0556 01-01-0558 01-01-0560 01-01-0562 01-01-0564 01-01-0566

    FDA Recall
    Open, Classified ·Synovo Production·Product code KXB·May 30, 2023

    ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow¿ OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 7, 2016

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014