BEUDAMED
    16 results · 21ms · Sources: EU EUDAMED, US FDA

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    HDM97

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    HANISCH MEDICAL

    FDA UDI
    Hanisch Medical Ltda·07898663499292·H45-LID F/ INST.-STANDER---BLUE

    VariAx

    FDA UDI
    Stryker GmbH·04546540567475·DISTAL LATERAL FIBULA PLATE, 8 HOLE

    SKYLIGHT IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    JET THERAPY

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    DISTAL LATERAL FIBULA PLATE, 8 HOLE

    FDA Adverse Event
    Injury ·STRYKER LEIBINGER FREIBURG·Product code KTT·January 27, 2014

    STYLE 10 SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·June 2, 2025

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 30, 2007

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 18, 2013

    ENTRUST AT

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code LWS·March 16, 2011

    TUBING SET

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY GMBH·Product code DTZ·December 21, 2020

    InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever reduction. K080908

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare·February 5, 2014

    InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever reduction. K080908

    FDA Recall
    Terminated ·Philips Healthcare·Product code NCX·January 13, 2014

    BD PRECISIONGLIDE¿ NEEDLE

    FDA Adverse Event
    Injury ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·November 23, 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