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

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    APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES]

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UNKNOWN SCREW

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code PAO·February 4, 2015

    WAVEWRITER ALPHA 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 10, 2022

    CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ERTAPENEM 10UG BBL SENSI-DISC

    FDA 510(k)
    FDA Class 2 ·Microbiology

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·April 12, 2013

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code MMI·May 6, 2011

    LVT

    FDA Adverse Event
    Injury ·CARDINAL HEALTH SYSTEMS·Product code CBK·July 22, 2008

    COPELAND THN SHL COCR/HA HUMS3

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code KWS·August 28, 2025

    LIFE SCOPE PT

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·December 26, 2023

    LIFE SCOPE PT

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·December 8, 2023

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

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