BEUDAMED
    10 results · 23ms · Sources: EU EUDAMED, US FDA

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    Edwards eSheath Optima introducer set

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS

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

    Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·October 1, 2024

    SIDE KICK METER

    FDA Adverse Event
    Injury ·HOME DIAGNOSTIC, INC·Product code NBW·November 24, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 17, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 29, 2013

    TMETRIX PR

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·October 30, 2018

    Staclot LA 20 (REF 00594) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase phospholipid molecules (1, 2).

    FDA Enforcement
    Class II ·Terminated·Diagnostica Stago, Inc.·December 26, 2018

    CORAIL AMT STANDARD OFFSET NECK SEGMENT (STD), Pro. Code L20431 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·April 17, 2019