BEUDAMED
    13 results · 19ms · Sources: EU EUDAMED, US FDA

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    TEKMEDIC POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    LE PTA CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODEL 4222 AMBULATORY ECG MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AT HOME DRUG TEST PHARATECH

    FDA Adverse Event
    PHAMATECH·Product code MVO·September 24, 2003

    ELECSYS 2010 RACK

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·March 8, 2013

    IAB: 8FR - 40 CC FOS

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC·Product code DSP·January 14, 2011

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·July 23, 2014

    TPRLC XR MP T1 PPS 12X109MM

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LPH·November 8, 2024

    TPRLC 133 T1 PPS SO 14X148MM

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LZO·November 8, 2024

    TPRLC 133 T1 PPS SO 15X150MM

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LZO·November 8, 2024

    TPRLC 133 MP TYPE1 PPS HO 12.0

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWA·November 8, 2024

    LOCATOR Implant Attachment System. The LOCATOR Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878

    FDA Recall
    Terminated ·Zest Anchors LLC·Product code DZE·January 16, 2014

    LOCATOR¿ Implant Attachment System. The LOCATOR¿ Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR¿ Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878

    FDA Enforcement
    Class II ·Terminated·Zest Anchors LLC·February 12, 2014