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

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    HEATER COOLER UNIT, MODEL HCU 30

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0315040·Probe, 1.5 inch Ball, Lenke, Straight, Impaction

    HADGEL, 4 GRAM/SYRINGE

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

    VAGINAL APPLICATOR SHIELDED

    FDA 510(k)
    FDA Class 2 ·Radiology

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 2, 2013

    ZOOM CRITICAL CARE BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·March 21, 2011

    PHOENIX

    FDA Adverse Event
    Other ·GAMBRO DASCO·Product code KDI·March 31, 2008

    ALINITY M RESP-4-PLEX AMP KIT

    FDA Adverse Event
    Malfunction ·ABBOTT MOLECULAR, INC.·Product code QJR·March 25, 2025

    Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025

    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

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013