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

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    Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Oph. Cystotomes

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113707·CYSTOTOME FORMED 23GA

    PAPILLON MASK SET

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OPTIMA MR 430S

    FDA 510(k)
    FDA Class 2 ·Radiology

    SENSOR ENLITE

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OZO·November 4, 2014

    ALARIS

    FDA Adverse Event
    Malfunction ·CARDINAL HEALTH·Product code FPA·August 21, 2011

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·July 12, 2013

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

    Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018