BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

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    Penumbra System (Reperfusion Catheter RED 43)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Pressure Sentinel®

    FDA UDI
    Zimmer, Inc.·00889024038776·

    Pressure Sentinel®

    FDA UDI
    Zimmer, Inc.·00889024038783·

    Brainance MD

    FDA 510(k)
    FDA Class 2 ·Radiology

    DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 UG OR LESS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    TEMA ELBOW SYSTEM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code JDB·September 26, 2024

    CANES

    FDA Adverse Event
    UNKNOWN·Product code IPS·November 4, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 25, 2011

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·July 12, 2013

    Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR. For the rapid, qualitative detection of human hemoglobin in feces.

    FDA Enforcement
    Class II ·Terminated·Polymedco, Inc·April 10, 2013

    UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·November 12, 2014

    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