BEUDAMED
    16 results · 25ms · Sources: EU EUDAMED, US FDA

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    NON-CONTACT TONOMETER, MODEL NT-4000

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SYSTEM 100; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILTRATION SET

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ALLEN MEDULLARY CEMENT PLUGS, ZIMMER POLY PLUG INTRAMEDULLARY SYSTEM, MODEL 8011 SERIES & 1109 & 8109 SERIES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD VACUTAINER® C&S TRANSFER STRAW KIT

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JSM·July 16, 2019

    I-STAT TROPONIN (CTNI) CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code MMI·February 14, 2012

    LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·April 2, 2013

    TOTALCARE BARIATRIC

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·March 21, 2011

    ELLIPSE VR, DF-4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·August 22, 2014

    BD VACUTAINER® C&S TRANSFER STRAW KIT

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JSM·July 29, 2019

    MYSTIQUE GCP SCREWS

    FDA Adverse Event
    Injury ·MACROPORE BIOSURGERY·Product code NDJ·November 22, 2006

    MYSTIQUE GCP

    FDA Adverse Event
    Injury ·MACROPORE BIOSURGERY·Product code NDJ·November 22, 2006

    i-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac I troponin measurement cane be used as an aid in the diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.

    FDA Enforcement
    Class II ·Terminated·Abbott Point Of Care Inc.·August 29, 2012

    The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016

    Spirit Plus Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    Spirit Select Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 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