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

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    COAT-A-COUNT(R) ESTRADIOL-6

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BARD INLAYOPTIMA URETERAL STENT WITH SUTURE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CYCLER 220 VOLT HOMECHOICE PROAUTOMATED PD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·December 30, 2010

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 21, 2013

    OT ULTRAMINI METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 18, 2014

    Colonoscope, Model Number PCF-H190DL.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·March 6, 2024

    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