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

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    XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED)

    FDA 510(k)
    FDA Class 2 ·Neurology

    INSET II

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 7, 2025

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0100220·Caddie, Rods, Adjustable Cross Links, and Caps

    Kalitec Special

    FDA UDI
    Kalitec Direct LLC·B073DRK0100120·Counter Torque, Offset

    Ocata Anterior Cervical System

    FDA UDI
    Kalitec Direct LLC·B07308K0100020·Caddie, Screws

    InTess C Cervical Cage System

    FDA UDI
    Kalitec Direct LLC·B07309K0100020·Impactor Head, Modular, InTess C

    Matira

    FDA UDI
    Kalitec Direct LLC·B07307K0100220·Assembly, Caddie, 1-3L Plates, Hnged

    Kalitec Special

    FDA UDI
    Kalitec Direct LLC·B073DRK0100020·Tap, 4.5mm Cann, Quarter Square

    MATIRA ANTERIOR CERVICAL SYSTEM

    FDA UDI
    Kalitec Direct LLC·B07307K0100020·Caddie, 1-3 Level Plates

    Kalitec Special

    FDA UDI
    Kalitec Direct LLC·B073DRK0100220·SNII Awl Tap, 6.50mm

    CONTOUR POLARIS URETERAL STENT

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

    GENERIC BLOOD GLUCOSE TEST STRIP

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    POLARIS ULTRA

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FAD·June 27, 2019

    COMPLETE DOUBLE MOIST

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code LPN·October 14, 2014

    AXSYM DIGOXIN III

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.·Product code KXT·May 11, 2007

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 19, 2013

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·February 11, 2011

    EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·July 30, 2014

    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