BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    PROTON THERAPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    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

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAW·February 14, 2024

    IMUFLEX DISPOSABLES

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION/TERUMO BCT·Product code CAK·April 17, 2013

    ZUK ARTICULAR SURFACE PROVISIONAL

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code JWH·March 18, 2011

    ENDEAVOR RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIO VASCULAR GALWAY·Product code NIQ·June 19, 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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015