BEUDAMED
    13 results · 36ms · Sources: EU EUDAMED, US FDA

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    TYCO BABY SESAME STREET SOFT TEETHER

    FDA 510(k)
    FDA Class 2 ·Dental

    KERATOME

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    THE MMG 5 IN 1 CONNECTOR

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·June 7, 2018

    CQUR MESH

    FDA Adverse Event
    Other ·ATRIUM MEDICAL CORP.·Product code FTL·January 2, 2013

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·January 11, 2011

    5.0CM SHORT ATTACHMENT

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·December 13, 2013

    HSG Pack, part number PSS3287

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

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HWC·March 8, 2016

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·March 11, 2016

    Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hip System intended for use during total hip arthroplasty. The acetabular insert is used in conjunction with PCA Acetabular Shells and Femoral Heads to restore hip joint biomechanics.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·November 25, 2015

    Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hip System intended for use during total hip arthroplasty. The acetabular insert is used in conjunction with PCA Acetabular Shells and Femoral Heads to restore hip joint biomechanics.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code JDI·October 15, 2015

    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