BEUDAMED
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    KENDALL SAFETRAK COMBINED EPIDURAL/SPINAL KIT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PROXIMAL HUMERUS PLATING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CEMENTEK

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ASR ACETABULAR CUPS 56

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·February 4, 2013

    ZIRCONIA

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, ORTHOPEDICS·Product code JDH·December 29, 2010

    CRUTCH

    FDA Adverse Event
    HEALTH PLUS HEALTH & MEDICAL·Product code IPR·July 17, 2014

    Hamilton brand Disposable Syringe Pack for use with Microlab F.A.M.E; Part Number: 147692 (case containing 96 syringes); Manufactured by: Treff AG, Degersheim, Switzerland for Hamilton Bonaduz AG, Bonaduz, Switzerland (Manufacturer of record); Product is distributed by Hamilton Company, Reno, NV The F.A.M.E Syringes are a disposable product that is used on our Microlab F.A.M.E. series instruments for diluting/dispensing. Microlab F.A.M.E was released under 510(k) K943493/S1 under product codes JJE (862.2160 Discrete Photometric Chemistry Analyzer for Clinical Use), JJQ (862.2300 Colorimeter, photometer, or spectrophotometer for Clinical Use), and JTC (866.2500 Microtiter Diluting/Dispensing Device), all of which are currently Class I exempt devices. The syringes are also used on Ortho Summit Processor instruments distributed by Ortho-Clinical Diagnostics.

    FDA Recall
    Terminated ·Hamilton Co·Product code JJE·September 26, 2011