BEUDAMED
    19 results · 38ms · Sources: EU EUDAMED, US FDA

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    KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386

    FDA 510(k)
    FDA Class 2 ·Radiology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040117903·ARCHWIRE SLEEVES GREY .027

    Mini-Mono®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR70605501·Mini-Mono-Brackets Roth 'N' .018" 1000 Brackets...

    Klitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0603500·Tray, Base, 3.5"

    OTW MEGALINK SDS BILIARY STENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428

    FDA 510(k)
    FDA Class 2 ·Immunology

    SYRINGE 10ML LL W/NDL 20X1-1/2 RB

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·March 23, 2020

    Widex

    FDA UDI
    Widex A/S·05706069898361·WIDEX EVOKE E-CIC-M (Clay brown ) 100

    Widex

    FDA UDI
    Widex A/S·05706069898378·WIDEX EVOKE E-CIC-M (Dark brown ) 100

    Widex

    FDA UDI
    Widex A/S·05706069898354·WIDEX EVOKE E-CIC-M (Light beige ) 100

    OXF UNI TIB TRAY SZ B LM PMA

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code NRA·January 26, 2018

    OXF TWIN-PEG CMNTD FEM MD PMA

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code NRA·January 26, 2018

    PERFORATOR DRIVER W/HUDSON END

    FDA Adverse Event
    Malfunction ·THE ANSPACH EFFORT, INC.·Product code HBE·April 10, 2013

    ATB ADVANCE PTA DILATION CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQY·June 12, 2008

    ASR ACETABULAR CUPS 52

    FDA Adverse Event
    Injury ·DEPUY INTL. LTD.·Product code KWA·April 6, 2011

    BIOMET 3i, PROVIDE IMPRESSION COPINGS, Catalog # PIC484, PIC484H, PIC485, PIC485H, PIC654, PIC654H, PIC655, and PIC655H BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·January 13, 2016

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022