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

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    KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ELECSYS DHEA-S CALCHECK

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    OMNIPOD 5 CONTROLLER

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code QFG·July 21, 2022

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS·Product code LYJ·March 27, 2013

    SYNCHRON® LX NO FOAM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·March 18, 2011

    SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE

    FDA Adverse Event
    Other ·GENZYME BIOSURGERY (SEPRAFILM/PACK)·Product code MCN·March 21, 2008

    AS COLUMBUS REV F FEMUR ZEMENTIERT F5L

    FDA Adverse Event
    Injury ·AESCULAP AG·Product code JWH·November 6, 2019

    OMNIPOD 5 CONTROLLER

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code QFG·August 22, 2022

    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

    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