BEUDAMED
    19 results · 24ms · Sources: EU EUDAMED, US FDA

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    J2I IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694003438·48mm 6 Hole EDC Plate

    Bright Tray

    FDA UDI
    ORMCO CORPORATION·00889989059779·BRIGHT TRAY-LOWER-SIZE 12-PINK-PK 20

    Merit® Kit

    FDA UDI
    Merit Medical Systems, Inc.·00884450256343·

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K1100520·Caddie, 6.5mm Screws

    FINE SURGICAL CIRCUMCISION CLAMP

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    CVINSIGHT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STELLARIS ELITE VISION ENHANCEMENT SYSTEM

    FDA Adverse Event
    Injury ·BAUSCH + LOMB·Product code HQC·March 1, 2022

    25 GA POSTERIOR WIDE-FIELD ELITE PACK

    FDA Adverse Event
    Malfunction ·BAUSCH + LOMB, INC·Product code HQC·December 6, 2019

    MAX PRI DCM TIB BRNG12X71/75MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·May 15, 2018

    ACCENT DR RF

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

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    FDA Adverse Event
    Malfunction ·REYNOSA MANUFACTURING·Product code FKX·May 29, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·June 25, 2011

    DCM MAXIM PRIMARY TIBIAL BEARING

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HRY·January 4, 2018

    STELLARIS POWER SUPPLY II

    FDA Adverse Event
    Malfunction ·BAUSCH + LOMB·Product code HQC·August 1, 2023

    MAXIM PRI TIBIAL BEARING 12X71/75

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·August 16, 2017

    TI LOW PROFILE SCREW 6.5X25MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·May 15, 2018

    TI LOW PROFILE SCREW 6.5X40MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·May 15, 2018

    Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc. Oncology Systems·May 22, 2013