BEUDAMED
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    ADT MENGHINI TYPE SOFT TISSUE BIOPSY

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

    MGB Alert HHV-6 Primer Mix ASR - 48 rxn

    FDA UDI
    Elitechgroup Mdx LLC·03661540951497·"MGB Alert® HHV-6 Primer Mix contains chemicall...

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756016056·ARM SLING

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867042360·STAPLE, COMPRESSION, SS, 15I X 15L

    DEVICE MODIFICATION TO PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OIS-2500 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    BIODESIGN 4-LAYER TISSUE GRAFT

    FDA Adverse Event
    Injury ·COOK BIOTECH, INC.·Product code FTM·April 3, 2014

    CONTOUR CURVED CUTTER STAPLER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 22, 2012

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code NBW·September 28, 2007

    regard Item Number: 800415, Sterile, OR0484 - Shoulder System Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·October 14, 2015

    Compounding Brochure titled ''Nutrition Compounding Simplified'', Lit #800415, print date January 2002; the brochure is applicable to the Automix Plus High Speed Compounder System, product 2M8075, the Automix High Speed Compounder System, product 2M8077, the Automix 3+3 Compounder System, product 2M8286, the Automix 3+3 Compounder with Accusource Monitoring System, product 2M8287, the Micromix Compounder System, 1.0 mL, product 2M8290, and the Micromix Compounder System, 0.3 mL, product 2M8290L; Baxter Healthcare Corporation, Clintec Nutrition, One Baxter Parkway, Deerfield, IL 60015

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code LHI--·April 30, 2004

    regard Item Number: 800415, Sterile, OR0484 - Shoulder System Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

    FDA Recall
    Terminated ·Resource Optimization & Innovation Llc·Product code FSY·April 22, 2015