BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    FERRITIN CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NAMIC CONTRAST SAVINGS DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    I REVIEW SOFTWARE(ACCESSORY TO) ILAB ULTRASOUND IMAGING SYSTEM) VERSION1.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    SET SCREW, TI GAMMA3® Ø8X17.5MM

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA KIEL·Product code HSB·July 22, 2014

    ALERE TOX SCREEN DRUG CUP

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code DKZ·May 30, 2014

    3.5MM PELVIC CORTEX SCREW SELF-TAPPING 70MM

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code HWC·February 15, 2013

    X8000 LIGHTSOURCE

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·January 11, 2011

    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