BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

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    DVT60

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BIOSENSORS CENTRAL VENOUS CATHETER KITS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    POWDERFREE NITRILE NEOPRENE EXAMINATION GLOVES (PULPLE)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    AMS SPHINCTER 800 URINARY PROSTHESIS

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code MIP·March 22, 2013

    FREESTYLE FREEDOM LITE

    FDA Adverse Event
    Injury ·Product code NBW·March 17, 2011

    APEX MONORAIL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code LOX·March 28, 2008

    INCLUSIVE TAPERED IMPLANT 5.2 MMD X 11.5 MML X 4.5 MMP

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·November 22, 2022

    WEREWOLF FLOW 90 COBLATION WAND

    FDA Adverse Event
    Malfunction ·ARTHROCARE CORP.·Product code GEI·October 23, 2019

    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

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012