BEUDAMED
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    FLEX ENDOSCOPIC INSTRUMENTS

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

    ForPro

    FDA UDI
    Tng Worldwide, Inc.·00672047101257·Black Nitrile Gloves Size X-Large 100ct

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017781·K-Wire, Double Ended, Trocar Point, Diameter Si...

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017798·K-Wire, Double Ended, Trocar Point, Diameter 0....

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·March 16, 2020

    FEMVUE CORNUAL BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    VECTRA GENISYS (MODULE & TRANSPORTABLE) AND INTELECT XT (MODULE & TRANSPORTABLE) LASER SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·October 3, 2014

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·May 31, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 27, 2011

    Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S. Indicated for use as a magnetic resonance diagnostic device (MRDD).

    FDA Enforcement
    Class II ·Terminated·Deerfield Imaging·March 23, 2016

    PKG, AXIAL HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080235. 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