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

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    BioPoly Lesser Toe Hemiarthroplasty Implant

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VERSAJET Hydrosurgery System (III)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    iBed Wireless with iBed Mobile

    FDA 510(k)
    FDA Class 2 ·General Hospital

    200 MICRON TFL SINGLE USE FIBER

    FDA Adverse Event
    Malfunction ·GYRUS ACMI, INC.·Product code GEX·March 7, 2023

    TENDRIL SDX

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2008

    8800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 10, 2011

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 10, 2013

    SOLTIVE PREMIUM SUPERPULSED LASER SYSTEM

    FDA Adverse Event
    Malfunction ·GYRUS ACMI, INC.·Product code GEX·March 7, 2023

    SpiraLok 5.0mm with Ethibond without needles Product Number: 222964 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow

    FDA Enforcement
    Class II ·Terminated·DePuy Mitek, Inc., a Johnson & Johnson Co.·October 31, 2012

    SpiraLok 5.0mm with Ethibond without needles Product Number: 222964 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow

    FDA Recall
    Terminated ·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code HWC·September 6, 2012

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025