BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    HANDI-FOAM

    FDA 510(k)
    FDA Class 2 ·Radiology

    Barco

    FDA UDI
    Barco NV·05415334002982·MDSC-8255 12G

    Barco

    FDA UDI
    Barco NV·05415334024106·MDRC-1219 HB

    OMNI Knee

    FDA UDI
    Omni Life Science, Inc.·00841690101215·Congruent Tibial Insert, Size 2 x 11mm

    ACETATE CONCENTRATES FOR HEMODIALYSIS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    TPN TRAY (STERILE)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HEARTSTART ONSITE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·January 14, 2013

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·December 21, 2010

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·July 15, 2014

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022