BEUDAMED
    12 results · 25ms · Sources: EU EUDAMED, US FDA

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    PMT HALO SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    Phonak

    FDA UDI
    Phonak AG·07612847819054·Phonak Ambra SP (light pink)

    QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    PVS 1500 SDS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VASOVIEW 6 ACCESSORY PACK

    FDA Adverse Event
    Malfunction ·MAQUET CV·Product code GCJ·January 10, 2019

    VASOVIEW 6 ACCESSORY PACK

    FDA Adverse Event
    Malfunction ·MAQUET CV·Product code GCJ·January 10, 2019

    VASOVIEW 6 ACCESSORY PACK

    FDA Adverse Event
    Malfunction ·MAQUET CV·Product code GCJ·January 10, 2019

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LZG·May 2, 2013

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code FKX·September 15, 2014

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    FDA Adverse Event
    Injury ·ALLERGAN·Product code LTI·April 19, 2011

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    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