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

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    Zavation eZspand Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ARCHER SUPER STIFF GUIDEWIRES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FLEXICAP

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

    DORNIER COMPACT DELTA

    FDA Adverse Event
    Malfunction ·DORNIER MEDTECH SYSTEMS GMBH·Product code LNS·July 27, 2011

    LIFEPAK CR PLUS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·September 26, 2008

    Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # AR-503-TTTD, Size 4 -Catalog # AR-503-TTTE, Size 5 - Catalog # AR-503-TTTF, Size 6 - Catalog # AR-503-TTTG , Size 7 -Catalog # AR-503-TTTH, and Size 8 - Catalog # AR-503-TTTJ. Intended for implantation with bone cement, with the exception of the porous coated femoral components which can be used cemented or uncemented (biological fixation).

    FDA Enforcement
    Class II ·Terminated·Arthrex, Inc.·March 30, 2016

    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