BEUDAMED
    13 results · 26ms · Sources: EU EUDAMED, US FDA

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    CONTRAST CONTROL DEVICE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Modulus

    FDA UDI
    Nuvasive, Inc.·00195377049339·Modulus ALIF Trial, 10x34x28mm 10°SmDeep

    Polystar Selection EDITION

    FDA UDI
    Merz Dental GmbH·D7091982123·posteriors; shade D4; size L; lower jaw

    Sklar

    FDA UDI
    SKLAR CORPORATION·10649111003400·YASARGIL RASP WIDE ANG 7.5 INCHES

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471123090·K-WIRE - DOUBLE TROCAR 1.2mm DIA x 75mm

    MULTIPLICITY OF PRODUCTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ENDO CATCH GOLD

    FDA Adverse Event
    Injury ·DAVIS & GECK CARIBE LTD·Product code GCI·June 11, 2018

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 8, 2013

    30 G SHORT PLASTIC

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code DZM·January 14, 2011

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·August 5, 2014

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    e.cam line of gamma camera systems Used to detect or image the distribution of radionuclides in the body or organ.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·October 29, 2014