BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Neurology

    PHILIPS EASY VISION FAMILY WORKSTATION OPTION MR QUANTITATIVE FLOW

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION OF NC-STAT

    FDA 510(k)
    FDA Class 2 ·Neurology

    1.6MM WIRE SLEEVE

    FDA Adverse Event
    Malfunction ·SYNTHES BRANDYWINE·Product code FZX·March 27, 2013

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·March 8, 2011

    CLEARSTAR PUMP

    FDA Adverse Event
    Malfunction ·ROSS PRODUCTS DIVISION·Product code LZH·April 2, 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

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018