BEUDAMED
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    EMERGENCY TRACHEOSTOMY INSTRUMENT SET

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    18PG - Eye Wash Station WC

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588226187·18PG - Eye Wash Station WC

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690113829·PS-C Insert, Size 6 x 18mm

    Legacy

    FDA UDI
    Gc Orthodontics America Inc.·E53582261800001·LEGACY 1. MOLAR UPR LFT SZ 18

    BIOFIRE FILM ARRAY GASTROINTESTINAL GI PANEL

    FDA Adverse Event
    Malfunction ·BIOMERIEUX / BIOFIRE·Product code JJH·March 30, 2018

    EMIT-STM ETHYL ALCOHOL URINE CONTROLS

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    X-SCRIBE II

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·June 5, 2015

    RESTORE ADVANCED RECHARGEABLE

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·August 27, 2010

    PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012