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

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    MITEK RAPIDLOC-PDS MENISCAL REPAIR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 5, 2024

    STARTOX DRUG OF ABUSE SCREENING TEST (4)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CASHMERE NON-STERILE, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRAM

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SEE H10

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KXA·November 1, 2011

    LIFEVEST WCD 3000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·March 1, 2013

    UNKNOWN DEPUY ASR ACETABULAR CUP

    FDA Adverse Event
    Malfunction ·DEPUY INTERNATIONAL, LTD.·Product code KWA·March 2, 2011

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code MAF·April 2, 2008

    BD NEEDLE ECLIPSE 25X5/8

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·September 22, 2024

    BD NEEDLE ECLIPSE 25X5/8

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·October 4, 2024

    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