BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    PROSPECT MICROPLATE ASSAY

    FDA 510(k)
    FDA Class 1 ·Microbiology

    EVERTAN SUNTAN BEDS

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

    DOCUMENT TOTAL AND DIRECT BILIRUBIN LINEARITY-MOD

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    FRESENIUS 2008K

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·June 27, 2014

    NEXGEN LPS FEMORAL COMPONENT

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code JWH·November 23, 2010

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code EZW·January 30, 2013

    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