BEUDAMED
    15 results · 25ms · Sources: EU EUDAMED, US FDA

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    Voxel Dosimetry™ v1.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    Novo Surgical

    FDA UDI
    NOVO SURGICAL, INC.·00842331122262·Titanium Bipolar Bayonet Forceps, (malis type) ...

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690198994·AK3 Congruent Insert Trial Size 2, 16mm

    Responsive Orthopedics Total Knee Arthroplasty System

    FDA UDI
    RESPONSIVE ORTHOPEDICS, LLC·00841973107644·TRIAL 90-SRK-191216 POLY-MPCS 2X16 RIGHT

    HAMILTON-C1

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·August 30, 2024

    CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AUDIT MICROCV PROTEIN LINEARITY SET

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CLINITEK STATUS+

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JHI·December 2, 2019

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·July 19, 2011

    EXTENSION SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·June 26, 2013

    CYCLESURE BIOLOGICAL INDICATOR

    FDA Adverse Event
    Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code FRC·September 26, 2008

    BIO-COMP SWIVELOCK C, CLD 5.5X19.1MM

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code MAI·April 22, 2020

    HTR-PMI S.B.1998-191216 LEFT FRONTAL TEMPORAL PARIETAL IMPLANT

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code KKY·April 3, 2020

    BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

    FDA Enforcement
    Class II ·Ongoing·FUJIFILM Healthcare Americas Corporation·August 6, 2025