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

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    CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    APL IGA ELISA KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    STEREOS WORKSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·September 5, 2024

    NV GXL LINER LIPPED 32MM ID, GROUP 1 CUPS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·September 5, 2024

    ALT HA S CLR EXT

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code MEH·November 14, 2023

    IDENTITY DR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·January 13, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013

    1.8MM TI LOCKING SCREW

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code KWP·June 7, 2011

    NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·May 31, 2024

    NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·August 12, 2024

    BIOLOX DELTA FEMORAL HEAD 32MM OD, -3.5MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·October 3, 2024

    NV GXL LINER LIPPED 36MM ID GROUP 2

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·November 1, 2022

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019

    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