BEUDAMED
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    ACCU-CHEK Guide Blood Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NUTRISAFE 2

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

    CLAVICLE LOCKING PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    THRUWAY GUIDE WIRES

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQX·March 7, 2011

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·June 16, 2011

    DRILL BIT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPEDICS·Product code HTW·September 12, 2008

    Artis zeego, Material no. 10280959 , for angiography and whole body radiographic/fluoroscopic procedures.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 4, 2018

    Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients. Procedures that can be performed with the AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 6, 2017

    Artis zee Biplane, Model No. 10094141; Artis zee Ceiling, Model No. 10094137; Artis zee Floor, Model No. 10094135; Artis zeego, Model No. 10280959 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·March 25, 2020