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

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    FP(HEXAFOCON A)RGP CONTACT LENS SPHERICAL/ASP(HEXAFOCON A)RGP CONTACT LENS ASPHERICAL

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MEDIS 55MP1H SINGLE-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    GOVAN+ WHEELCHAIR AND DOCKING ACCESSORY

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    TOTAL ASR ACET IMP SIZE 60

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·September 11, 2013

    DEPUY ASR XL FEM IMP SIZE 53

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KXA·September 11, 2013

    ACCU-CHEK ® COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·March 26, 2013

    ARCHITECT HAVAB IGM REAGENT

    FDA Adverse Event
    Malfunction ·ABBOTT·Product code LOL·March 17, 2011

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·March 19, 2008

    DHF 06 HEMOCONCENTRATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALY·Product code KDI·May 22, 2025

    NEEDLE FILTER BLUNT FILL 18X1-1/2

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code GAA·May 6, 2025

    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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014