BEUDAMED
    12 results · 28ms · Sources: EU EUDAMED, US FDA

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    HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450285947·

    OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND CABLES (AKA ACCESSORIES)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    THE BREATHE EZ ANTI-SNORING DEVICE

    FDA 510(k)
    FDA Class 2 ·Dental

    NONE - SEE PHYSICIAN COMMENTS IN H10.

    FDA Adverse Event
    Injury ·Product code JWH·October 16, 2013

    MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 11, 2021

    RESTORE SENSOR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 11, 2013

    AMS MALLEABLE

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FAE·May 15, 2008

    CONTAK RENEWAL

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 13, 2011

    SIMULUS FULLY FLEXIBLE ANNULOPLASTY BAND

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·September 30, 2020

    VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·September 9, 2015

    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