BEUDAMED
    59 results · 22ms · Sources: EU EUDAMED, US FDA

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    SJM CONFIRM IMPLANTABLE CARDIAC MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ceramco®

    FDA UDI
    Dentsply International Inc.·D0011220900·

    ArgenZ HT+ 98x22 OM2

    FDA UDI
    ARGEN CORPORATION, THE·D818122090·Dental porcelain/ceramic restoration kit

    16PW - Class A 21 Lawson - Poly White

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588620909·16PW - Class A 21 Lawson - Poly White

    Forestanit®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR21220901·Forestanit wire round hard laboratory coil 0,90 mm

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K1220100·Breaker, Extended Tab

    SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYNTEX PRE-POWDERED NITRILE EXAMINATION GLOVE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·May 16, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 26, 2014

    EXCEL 36KHZ MICROTIP PLUS BOX4

    FDA Adverse Event
    Malfunction ·INTEGRA, BURLINGTON·Product code LFL·May 24, 2011

    RADIFOCUS GLIDEWIRE ADVANTAGE

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·May 1, 2020

    GLIDEWIRE ADVANTAGE

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·July 9, 2025

    RADIFOCUS GLIDEWIRE ADVANTAGE

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 23, 2022

    M2A-MAGNUM PF CUP 52ODX46ID

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·October 9, 2017

    COOK TURBO-FLO HD HEMODIALYSIS CATHETER SET

    FDA Adverse Event
    Injury ·COOK INC·Product code MPB·February 13, 2017

    CAPIOX RX OXYGENATOR

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·March 28, 2019

    RADIFOCUS GLIDEWIRE ADVANTAGE

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·February 3, 2025

    SOMATOM Edge Plus-Computed tomography system Model 1026700

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·January 19, 2022

    SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021