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

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    GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIA

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

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496053552·MICROMASSAGE ARMBANDS CCL1, SIZE XL, NOISETTE, ...

    ITI DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    JAX-TCP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    FDA Adverse Event
    ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code NVY·January 15, 2014

    VITALITY 2

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 11, 2013

    CONSULTA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·April 13, 2011

    BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·January 6, 2022

    Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015