BEUDAMED
    11 results · 27ms · Sources: EU EUDAMED, US FDA

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    ACTIVE PSA ELISA (DSL-10-9700)

    FDA 510(k)
    FDA Class 2 ·Immunology

    Access Myoglobin

    FDA UDI
    Beckman Coulter, Inc.·15099590231682·The Access Myoglobin assay is a paramagnetic pa...

    LED PRO SEAL

    FDA 510(k)
    FDA Class 2 ·Dental

    BRAIN HEART INFUS AGAR SLT W/5% SHEEP BLOOD #T3286

    FDA 510(k)
    FDA Class 1 ·Microbiology

    MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244

    FDA 510(k)
    FDA Class 2 ·Immunology

    THUNDERBEAT 5 MM 35 CM FRONT-ACTUATED GRIP

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code GEI·June 6, 2014

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    FDA Adverse Event
    Injury ·UNKNOWN·Product code FNL·February 21, 2013

    MINI-CAP WITH POVIDONE LODINE

    FDA Adverse Event
    Malfunction ·Product code KDI·January 28, 2011

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code MMI·June 17, 2012

    Access Myoglobin Reagents Kits, Part Number: 973243. The Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Myoglobin levels in human serum and plasma using the Access Immunoassay Systems.

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code DDR·September 27, 2007

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

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