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

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    ETEST FOR QUINUPRISTIN/DALFOPRISTIN

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SCARLET AL-T

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LIGACLIP CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·August 11, 2015

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·ANIMAS CORP.·Product code LZG·February 7, 2011

    REVEAL LINQ

    FDA Adverse Event
    Malfunction ·IPG MFG SWITZERLAND·Product code DSI·August 8, 2014

    PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma

    FDA Enforcement
    Class II ·Terminated·Ra Medical Systems Inc·August 6, 2014

    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

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023