BEUDAMED
    9 results · 25ms · Sources: EU EUDAMED, US FDA

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    HYDROGEN PEROXIDE TOPICAL; FORMALDEHYDE

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

    SureCore Automatic Disposable Biopsy Needle

    FDA UDI
    Canyon Medical Inc.·06954414640854·Automatic Disposable Biopsy Needle

    GE ECHOPAC

    FDA 510(k)
    FDA Class 2 ·Radiology

    IQL BASIC FRAGMENT PLATE SET, IQL BASIC FRAGMENT SCREW SET, IQL SMALL FRAGMENT SET, IQL MINI FRAGMENT SET

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 9, 2014

    GREENLIGHT HPS BPH FIBER OPTIC

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS·Product code GEX·October 31, 2012

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 4, 2015

    MMT-712 PARADIGM INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LZG·March 23, 2021

    EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.

    FDA Enforcement
    Class II ·Terminated·Dako North America Inc.·November 11, 2015