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

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    OMNI STIK

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    Darby Dental Supply, LLC

    FDA UDI
    DARBY DENTAL SUPPLY, LLC·00889813056509·WIRE NI-TEK LOWER .016X.016 PKG/10

    Archon

    FDA UDI
    Nuvasive, Inc.·00887517658906·Archon Screw, Ø4.5x16mm Self Drill Vari

    API 20A

    FDA 510(k)
    FDA Class 1 ·Microbiology

    PSM 3-Way Silicone Foley Catheter

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

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 30, 2014

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC., USA·Product code LFR·June 21, 2007

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 10, 2012

    Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.

    FDA Enforcement
    Class II ·Terminated·Coloplast Manufacturing US, LLC·December 2, 2020