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

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    Hair Removal Device, Model(s): R2815-G Pro, R2815-G

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Symmetry Cobb

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482001691·Symmetry® Curette, Cobb, Size 3, Tip 5.5 mm Wid...

    PASS LP SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FIRST SIGN DRUG OF ABUSE SCREENING TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·November 13, 2008

    MESH - COMPOSIX

    FDA Adverse Event
    Injury ·DAVOL INC·Product code FTL·August 24, 2011

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 18, 2013

    The Acumed Tension Band Pin is a fixation pin which is .0625" in diameter and is available in lengths between 35mm and 90mm. It is to be used in conjunction with commonly used orthopedic wire. 50.0 mm Tension Band Pin; Part Number 30-0097 70.0 mm Tension Band Pin; Part Number 30-0098 90.0 mm Tension Band Pin; Part Number 30-0099 50.0 mm Tension Band Kit; Part Number TB-1550K-S 70.0 mm Tension Band Kit; Part Number TB-1570K-S 90.0 mm Tension Band Kit; Part Number TB-1590K-S Product Usage: Acumed Tension Band Pin is intended to be used with orthopedic wire to address malleolar, patella, and olecranon fractures in tension band wiring procedures. This device is not intended for usage in the spine.

    FDA Enforcement
    Class II ·Terminated·Acumed LLC·May 7, 2014