BEUDAMED
    11 results · 17ms · Sources: EU EUDAMED, US FDA

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    ARTUS DISPOSABLE SHEATHS/CUTTERS

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

    CURE CATHETER CLOSED SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    HemoSphere Advanced Monitor, HemoSphere Pressure Cable

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·January 30, 2014

    ENDOSTAT ELECTROSURGICAL UNIT

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code KNS·October 25, 2010

    CANCELLOUS SCREW

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code DZL·December 20, 2012

    Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.

    FDA Enforcement
    Class II ·Ongoing·LEICA BIOSYSTEMS NUSSLOCH GMBH·August 14, 2024

    Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM

    FDA Enforcement
    Class II ·Ongoing·Onkos Surgical, Inc.·June 4, 2025

    SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037

    FDA Enforcement
    Class II ·Completed·Townsend Design·January 17, 2024

    HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006411

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·June 12, 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