BEUDAMED
    10 results · 20ms · Sources: EU EUDAMED, US FDA

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    PNK Total Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    IMSURE

    FDA 510(k)
    FDA Class 2 ·Radiology

    BONE SCREW

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MRA·July 21, 2020

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·April 22, 2024

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·November 6, 2014

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code MMI·September 1, 2011

    PLV-102

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC·Product code CBK·July 15, 2013

    CONTINUUM SHELL

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·July 21, 2020

    Philips Zenition 50, Model Number: 718096

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024