BEUDAMED
    10 results · 20ms · Sources: EU EUDAMED, US FDA

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    TREBAY IRRIGATED CUTTER BLADE (MODIFICATION)

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    TRANSDUCER PROTECTOR

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

    ANGIOMED GUIED WIRES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD BBL¿ MGIT¿ OADC ENRICHMENT

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code MDB·May 13, 2024

    S-ROM M HEAD 36MM +3

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·February 11, 2013

    PENTA

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·July 16, 2014

    DURATA STS OPTIM PASSIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 10, 2011

    Morris Hysto Pack, part number PSS3198(A

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

    Model 055: Thermophore Classic, Professional Quality, Deep-Heat Therapy, Model 055 Large 14' x 27", Model 056: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 056 Medium 14" x 14", Model 077: Thermophore Classic Professional Quality Deep-Heat Therapy, Model 077 Petite 4"x 17",Model 095: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 095 Large 14" x 27 Model 096: Thermophore Classic, Professional Quality Deep-Heat therapy Model 096, Medium, 14" x 14" Model 097: Thermophore Classic, Professional quality Deep-Heat Therapy, Model 097 , Petite, 4" x 17", Model 255: Thermophore Classic Plus, Professional Quality Deep-Heat Therapy, Model 255 Large,14" x 27", Model 256: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 256, Medium, 14" X 14 Model 277: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 277, Petite , 4" x 17" Used for the temporary relief of joint and muscle pain.

    FDA Enforcement
    Class II ·Terminated·Battle Creek Equipment Co.·November 9, 2016

    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