BEUDAMED
    10 results · 26ms · Sources: EU EUDAMED, US FDA

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    PFI-20 POLARIZING FLUORIMETER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    NA

    FDA UDI
    STERILMED, INC.·10888551017626·SAW BLADE OSCILLATING LARGE BONE

    Sterile Latex Surgical Gloves, Powder Free

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS

    FDA 510(k)
    FDA Class 2 ·Radiology

    TAPERLOC POROUS FEMORAL STEM

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LPH·August 22, 2019

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 13, 2014

    PULSE GEN MODEL 103

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·December 13, 2012

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 26, 2015

    CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040

    FDA Enforcement
    Class II ·Completed·Townsend Design·January 17, 2024

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021