BEUDAMED
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    GAMBRO LUNDIA 94-500 DIALYZER

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

    SIMPLASTIN L

    FDA 510(k)
    FDA Class 2 ·Hematology

    REPLICA

    FDA 510(k)
    FDA Class 2 ·Dental

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·February 6, 2013

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·January 4, 2011

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 21, 2014

    TAPERLOC COMPLETE 133 MP TYPE1 PPS HO 17.0

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWA·August 14, 2024

    TAPERLOC COMPLETE 133 T1 PPS HO 15X150MM

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LZO·August 14, 2024

    TAPERLOC COMPLETE 133 MP TYPE1 PPS HO 17.0

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWA·August 14, 2024

    33CM DORSEY GRASPER FORCEPS, P/N 0250080319. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014