BEUDAMED
    14 results · 22ms · Sources: EU EUDAMED, US FDA

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    Microperimeter MP-3, Microperimeter MP-3 Type S

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Ophthalmic Retractor

    FDA UDI
    KATENA PRODUCTS, INC.·00841668101100·HELVESTON "GREAT BIG BARBIE" RETRACTOR 11MM

    BLUE SKY BIO TCP

    FDA 510(k)
    FDA Class 2 ·Dental

    JIAJIAN SELF-ADHESIVE ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Neurology

    T:SLIM G4 SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OYC·February 8, 2017

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·July 10, 2023

    CUTTING BALLOON

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code LIT·September 25, 2014

    MONACO

    FDA Adverse Event
    Malfunction ·ELEKTA INC.·Product code MUJ·July 28, 2021

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·May 16, 2019

    QUICKFLEX XL LV LEAD

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CRMD·Product code NIK·January 11, 2014

    HEARTSTART FRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 18, 2013

    IPUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

    MONACO

    FDA Adverse Event
    Malfunction ·ELEKTA INC·Product code MUJ·August 25, 2021

    Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty

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