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

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    Preat Abutments

    FDA 510(k)
    FDA Class 2 ·Dental

    PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS

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

    ELECSYS TSH

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JLW·October 10, 2022

    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 27, 2019

    LIFEVEST WCD 3000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·October 29, 2008

    OT ULTRAMINI METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·August 23, 2011

    2520274-2013-04146

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·July 11, 2013

    CAPIOX CUSTOM PACK

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·February 8, 2023

    VIDAS® ESTRADIOL II

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code CHP·February 10, 2022

    BD MICROLANCE ¿ 3 NEEDLES

    FDA Adverse Event
    Injury ·BECTON DICKINSON, S.A.·Product code FMI·August 28, 2023

    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 27, 2019

    BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers 722079 and 722224

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 11, 2024

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020