BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    ALPINE V

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CATHLAB SILICONE OCCLUSION BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACUSON C366 TRANSDUCER

    FDA 510(k)
    FDA Class 2 ·Radiology

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·November 17, 2010

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 5, 2014

    BASIC CONFIGURATION LD304 MODEL 4701

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code HDD·December 7, 2012

    Philips Zenition 50, Model Number: 718096

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024

    The LifeCare Pump Model 4200 PCA Infuser makes possible the practical implementation of patient-controlled analgesia. The health care professional sets the prescribed dose, rates, and limits for the drug to be infused. The infuser can be set to operate in one of three modes: PCA Mode, Continuous Mode, and PCA + Continuous Mode. The LifeCare Pump Model 4200 PCA Infuser is designed with a number of mechanical, electrical, and software safeguards that prevent patient injury or drug abuse.

    FDA Enforcement
    Class II ·Terminated·Hospira Inc.·July 20, 2016