BEUDAMED
    11 results · 18ms · Sources: EU EUDAMED, US FDA

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    URO MED NERVE STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    MODIFICATION TO SENTINEL CLIN CHEM CAL

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CARDIOZYME CK-CONTROL ABNORMAL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DENTAL FLOSS

    FDA Adverse Event
    Injury ·RANIR, LLC·Product code JES·June 30, 2014

    ALIGN S SUPRAPUBIC URETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·BARD SHANNON LIMITED·Product code FTL·February 15, 2013

    PLM CONV PN INTGRL F

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·January 6, 2011

    GELFOAM

    FDA Adverse Event
    Injury ·PFIZER, INC. (DEVICE)·Product code LMF·May 29, 2009

    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

    Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 5, 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