BEUDAMED
    18 results · 24ms · Sources: EU EUDAMED, US FDA

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    RUSCH EDGAR TUBE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Safco FG Diamonds

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310215403·FG Diamond 856-025 round end taper extra coarse...

    General Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00811801035289·Rib Derotation Set - Hook, Straight

    ONESTEP

    FDA UDI
    Zoll Medical Corporation·10847946016231·ONESTEP PEDIATRIC ELECTRODE (P/N 8900-0218-40),...

    EPOC READER

    FDA Adverse Event
    Malfunction ·EPOCAL INC.·Product code CGL·January 25, 2021

    VIEWPOINT CENTRAL MONITORING SYSTEM, MODEL 0998-00-0187-07

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BLY-501 ADAPTOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEMOSTATIC BONE PUTTY STERILE

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code MQV·March 26, 2013

    ZIPWIRE HYDROPHILIC GUIDE WIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQX·March 17, 2011

    COLLEAGUE 3 CXE VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE LTD.·Product code FRN·March 26, 2008

    CAPSUREFIX NOVUS MRI SURESCAN

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·May 6, 2022

    SPRINT QUATTRO SECURE MRI SURESCAN

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·May 6, 2022

    COBALT¿ XT HF QUAD CRT-D MRI SURESCAN¿

    FDA Adverse Event
    Injury ·MEDTRONIC EUROPE SARL·Product code NIK·May 6, 2022

    ATTAIN STABILITY QUAD MRI SURESCAN

    FDA Adverse Event
    Injury ·MPRI·Product code OJX·May 6, 2022

    GLUCOSE SENSOR (GLUCOSE SENSOR FREESTYLE LIBRE 14 DAY)

    FDA Adverse Event
    ABBOTT DIABETES CARE INC.·Product code MDS·June 21, 2021

    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