BEUDAMED
    19 results · 29ms · Sources: EU EUDAMED, US FDA

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    RESPIRONICS SLEEPEASY CPAP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Medtronic Reusable Instruments

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00673978958989·DISTRACTOR 9091112 12MM STRAIGHT 8 DEG

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690198901·AK3 Congruent Insert Trial Size 1, 12mm

    NA

    FDA UDI
    STERILMED, INC.·10888551021067·BUR LINDERMAN CARBIDE

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450215920·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450223222·

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07310K0191120·Dilator, Medium

    CYCLOSPORINE CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    GE MARQUETTE CLINICAL INFORMATION CENTER, GE MARQUETTE CIC

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 17, 2025

    EQUINOXE REVERSE SHOULDER COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·June 16, 2023

    EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code HSD·June 19, 2023

    PANORAMA CENTRAL STATION W/TELEPACK

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

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 16, 2014

    OPEN PIVOT MECHANICAL HEART VALVE

    FDA Adverse Event
    Death ·MEDTRONIC ATS, INC.·Product code LWQ·May 6, 2011

    BD LUER-LOK

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·November 29, 2023

    Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.

    FDA Enforcement
    Class II ·Terminated·Merit Medical Systems, Inc.·November 30, 2016

    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

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023