BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    XLTEK EMU40 EEG HEADBOX, MODEL PK1072

    FDA 510(k)
    FDA Class 2 ·Neurology

    NXSTAGE PUREFLOW SOLUTION

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

    SPECIAL PROCEDURES HEAD COIL; MODEL # 1100GE-64

    FDA 510(k)
    FDA Class 2 ·Radiology

    PROFILE BIABUT 4.0 -Ø5.5

    FDA Adverse Event
    Injury ·DENTSPLY IMPLANTS MANUFACTURING GMBH·Product code DZE·February 24, 2026

    UNKNOWN DEPUY FEMORAL HEAD

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWY·April 11, 2013

    CAPSURE VDD-2

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 13, 2011

    CONTOUR TEST STRIPS (50)

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·May 22, 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 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

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