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

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    SunClear Aligner system

    FDA 510(k)
    FDA Class 2 ·Dental

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306822605·Bow Retractors with teeth 1.25in , 32mm wide

    VALVED TEARWAY INTRODUCER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MULTI-PARAMETER PATIENT MONITOR, MODEL# PMS8210A

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·July 28, 2011

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 26, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 21, 2014

    G7 BISPHERICAL SHELL 50D

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LPH·August 26, 2020

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020