BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

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    REMEDY Acetabular Cup

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Oticon

    FDA UDI
    Oticon A/S·05707131340283·SIYA 2, KIT 312 NFM PB T L C001

    Sklar

    FDA UDI
    SKLAR CORPORATION·10649111442278·ADLERKREUTZ TISSUE FCP 4X5 10 INCHES

    LIGHTLAS 577 MEDICAL OPTICAL PUMPED SEMICONDUCTOR LASER

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    OPTETRAK LOGIC COMBINATION TIBIAL TRAY

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COCHLEAR OSIA OSI300 IMPLANT

    FDA Adverse Event
    Injury ·COCHLEAR LTD·Product code PFO·March 8, 2026

    TENDRIL STS

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code DTB·January 13, 2014

    REAGENT RED BLOOD CELLS BIOTESTCELL 1&2

    FDA Adverse Event
    Malfunction ·BIO-RAD MEDICAL DIAGNOSTICS GMBH·Product code KSZ·June 27, 2013

    SOLETRA

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·July 22, 2011

    LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·January 6, 2025

    bvi Beaver EdgeAhead Safety Knife, (a) Sideport MVR .90mm 20G, REF 370531 (b) Sideport Angled, .60mm (23G), REF 378233 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

    FDA Enforcement
    Class II ·Terminated·Beaver-Visitec International Inc.·February 7, 2018

    HANCOCK

    FDA Adverse Event
    Death ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·November 8, 2019

    HANCOCK

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·November 8, 2019

    LOGIC FEMORAL PS CEM RIGHT SZ 2

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·September 4, 2024

    OPTETRAK HI-FLEX TIBIAL INSERT SZ 4 11MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·August 25, 2022