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

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    THOMAS MEDICAL ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    POWDER FREE STERILE LATEX SURGICAL GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code KNS·March 15, 2019

    DINAMAP PROCARE SERIES MONITOR

    FDA Adverse Event
    Malfunction ·GE HEALTHCARE·Product code MWI·September 9, 2010

    DINAMAP PROCARE SERIES MONITOR

    FDA Adverse Event
    Malfunction ·GE HEALTHCARE·Product code MHX·September 9, 2010

    TRIDENT 0° X3 INSERT 32MM ID

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·March 27, 2013

    8MM MCS TIP COVER ACCESSORY

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·March 17, 2011

    5.5MM POLYAXIAL SCREW-OPEN 6.5 X 45

    FDA Adverse Event
    Injury ·ABBOTT SPINE·Product code HWC·April 1, 2008

    CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code KNS·February 4, 2019

    POD PACKING COIL

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·December 19, 2017

    CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code KNS·August 8, 2018

    CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code KNS·August 8, 2019

    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