BEUDAMED
    12 results · 27ms · Sources: EU EUDAMED, US FDA

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    INFINITI

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Safco FG Diamonds

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310215663·FG Diamond 858-014 needle fine (gold) 5/pack

    QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    FUJIREBIO DIAGNOSTICS CA 19-9 RIA

    FDA 510(k)
    FDA Class 2 ·Immunology

    RUBY COIL

    FDA Adverse Event
    Injury ·PENUMBRA, INC.·Product code HCG·November 22, 2019

    SYNDEO SYRINGE PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code MEA·October 8, 2009

    6.0MM FLEXIBLE MEDULLARY REAMER/FLAT WIRE/385MM

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HTO·March 26, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·March 8, 2011

    TRU-WAVE DISPOSABLE PRESSURE MONITOR AND VAMP COMBO

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DRS·March 24, 2008

    RUBY COIL

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·November 22, 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