BEUDAMED
    15 results · 31ms · Sources: EU EUDAMED, US FDA

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    EW-10 AND EW-20

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

    C-ARM REFERENCE UNIT LEFT

    FDA UDI
    Brainlab SE·04056481113940·

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100363·COOK EYE SPECULUM #2 SOLID

    MODEL #350 SHOCK-PLATE DEFIB ADAPTOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ANTIGENZ CHLAMYDIA

    FDA 510(k)
    FDA Class 2 ·Neurology

    4.5MM CORTEX SCREW SELF-TAPPING 30MM

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·October 21, 2020

    4.5MM CORTEX SCREW SELF-TAPPING 30MM

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·October 21, 2020

    4.5MM CORTEX SCREW SELF-TAPPING 30MM

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·October 21, 2020

    4.5MM CORTEX SCREW SELF-TAPPING 30MM

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·October 21, 2020

    4.5MM CORTEX SCREW SELF-TAPPING 30MM

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·October 21, 2020

    TRILOGY 202

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code CBK·June 4, 2014

    UNKNOWN ZIMMER KNEE

    FDA Adverse Event
    Malfunction ·ZIMMER INC·Product code JWH·November 4, 2010

    APPLIED MEDICAL KII ACCESS SYSTEM

    FDA Adverse Event
    Malfunction ·STERILMED, INC.·Product code GCJ·January 10, 2013

    EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE

    FDA Adverse Event
    Malfunction ·SHIRAKAWA OLYMPUS CORP. LTD.·Product code ODG·December 15, 2022

    EndoVive 3s Low Profile Balloon Kits Part Number: M00548220 (XMD P/N 70-0050-112) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

    FDA Enforcement
    Class II ·Terminated·Xeridiem Mediem Medical Devices Inc·March 2, 2016