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    MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST - INDUCIBLE CLINDAMYCIN

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MODIFIED MOSS MIAMI 4.35MM DIAMETER POLYAXIAL SCREWS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP-3BU1

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INFINION? CX

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·August 6, 2025

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 7, 2025

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·April 26, 2013

    APT DRIVER

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 21, 2011

    PFC SIG CRUC SUB SZ2.5 W/LG RT

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM/A DIVISION OF DEPUY ORTHOPAEDICS, INC·Product code JWH·July 23, 2008

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    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