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

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    INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FPA·January 3, 2023

    BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FPA·January 3, 2023

    Q-RAD System

    FDA UDI
    CARESTREAM HEALTH, INC.·60889971051493·Q-RAD SYSTEM/QGV-5000-4-R10-T740

    VISUALINE AMPHETAMINE DIPSTRIP ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PHORMAX EAGLE SCANNER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    PRUITT-INAHARA CAROTID SHUNT

    FDA Adverse Event
    Malfunction ·HORIZON MEDICAL PRODUCTS, INC.·Product code DQR·May 31, 2000

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·April 10, 2013

    ATTAIN BIPOLAR OVER THE WIRE LEAD

    FDA Adverse Event
    Injury ·MPRI·Product code LWP·April 12, 2011

    GEMINI PC-2

    FDA Adverse Event
    Malfunction ·ALARIS MEDICAL SYSTEMS, INC.·Product code FRN·May 12, 2008

    RD SET NEO CS-3

    FDA Adverse Event
    Malfunction ·MASIMO - 52 DISCOVERY·Product code DQA·January 29, 2021

    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 VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    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. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014