BEUDAMED
    13 results · 30ms · Sources: EU EUDAMED, US FDA

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    Preat Abutments

    FDA 510(k)
    FDA Class 2 ·Dental

    ZenFlex CM

    FDA UDI
    Kerr Corporation·00195062145568·.30/.04/31mm ZenFlex CM NiTi FILE REFILL PACK

    MICRO INSTRUMENT TRAY

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896075153·MICRO INSTRUMENT TRAY WITH MAT TITANIUM

    TRINITY ACETABULAR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACL ACUSTAR, HEMOSIL ACUSTAR D-DIMER, HEMOSIL ACUSTAR D-DIMER CONTROLS

    FDA 510(k)
    FDA Class 2 ·Hematology

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 22, 2013

    DEPUY ASR XL FEM IMP SIZE 51

    FDA Adverse Event
    Malfunction ·DEPUY INTERNATIONAL LTD - 8010379·Product code KWA·June 22, 2011

    RESERVOIR 1.8ML

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·October 18, 2014

    VALEO / VALEO II

    FDA Adverse Event
    Malfunction ·SINTX TECHNOLOGIES (FORMERLY AMEDICA CORP)·Product code MAX·March 25, 2020

    T2 STRATOSPHERE

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code MQP·July 1, 2020

    MIDAS REX MR8

    FDA Adverse Event
    Malfunction ·MDT POWERED SURGICAL SOLUTIONS·Product code HBC·May 9, 2025

    MOTOR MR8 ELECTRIC

    FDA Adverse Event
    Malfunction ·MDT POWERED SURGICAL SOLUTIONS·Product code HBB·February 24, 2022

    bvi Beaver Xstar Safety Crescent, 2.5mm, 55o Bevel Up, REF 378234 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