BEUDAMED
    13 results · 19ms · Sources: EU EUDAMED, US FDA

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    Medical Disposable Face Masks

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Pressure Sentinel®

    FDA UDI
    Zimmer, Inc.·00889024038790·

    Pressure Sentinel®

    FDA UDI
    Zimmer, Inc.·00889024038806·

    EZ SPLINT & EZ SPLINT PM

    FDA 510(k)
    FDA Unclassified ·Unknown

    Advin Multi-Drug Screen Test Cassette, Dip Card and Cup

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    FLOWART NEEDLE-FREE SPLIT SEPTUM VALVE

    FDA Adverse Event
    Malfunction ·ASSET MEDIKAL TASARIM SAN. TIC. A.S.·Product code FPA·July 24, 2025

    TEMA ELBOW SYSTEM

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

    MONOCRYL PLUS SUTURE

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAM·November 4, 2014

    OT ULTRALINK METER

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

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL,INC.·Product code NAY·July 12, 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

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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