BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    LSVT C OR LSVT COMPANION, MODEL V.1

    FDA 510(k)
    FDA Unclassified ·Unknown

    VSCORE WITH EKG SIGNAL GATING

    FDA 510(k)
    FDA Class 2 ·Radiology

    OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODELS HEM-773, HEM-773AC

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PROMOTE RF CRT-D

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL INC., CRMD·Product code NIK·January 13, 2014

    DPM3 MONITOR

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC.·Product code DQA·April 30, 2013

    MINICAP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·May 17, 2011

    BLUNT TIP SCREW, 4X36MM

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·September 25, 2023

    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