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

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    ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5

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

    MICOR CONDUCTION CATHETER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PROMUS PREMIER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·May 4, 2021

    BD CATHENA¿ SAFETY IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·May 19, 2022

    7.0MM TI MATRIX POLYAXIAL SCREW 40MM THREAD LENGTH

    FDA Adverse Event
    Malfunction ·SYNTHES BRANDYWINE·Product code NKB·March 26, 2013

    BAXTER INTERLINK SYSTEM NON DEHP THREE LEAD EXTENSION

    FDA Adverse Event
    Injury ·BAXTER·Product code FPA·March 14, 2011

    2800

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

    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

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021