BEUDAMED
    12 results · 26ms · Sources: EU EUDAMED, US FDA

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    VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Young

    FDA UDI
    YOUNG DENTAL MANUFACTURING I, LLC·00302731537122·Young DPA Contra, Latex Free, Turbo Plus, Firm...

    GRYPHON PEEK DS ANCHOR W/ ORTHOCORD, GRYPHON PEEK ANCHOR W/ ORTHOCORD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IM-11 PNEUMATIC MICROINJECTOR

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

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 7, 2011

    PROTECTA XT CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC EUROPE SARL·Product code NIK·June 8, 2013

    RIATA PASSIVE FIXATION

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·October 8, 2014

    PATIENT INFORMATION CENTER IX

    FDA Adverse Event
    Death ·PHILIPS MEDICAL SYSTEMS·Product code MHX·March 15, 2023

    PATIENT INFORMATION CENTER IX

    FDA Adverse Event
    Death ·PHILIPS MEDICAL SYSTEMS·Product code MHX·November 9, 2023

    Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·February 18, 2015

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

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