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

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    HARDYDISK AZITHROMYCIN 15MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    URETEROPYELOGRAM CATH FOR RETROGRADE DYE INJECTION

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

    IF2000 ELECTRICAL MUSCLE STIMULATOR UNIT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    M2A-MAGNUM PF CUP 48ODX42ID

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·March 8, 2013

    SPRINT

    FDA Adverse Event
    Malfunction ·MPRI·Product code LWS·August 8, 2014

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·February 16, 2011

    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

    Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers 722079 and 722224

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 11, 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

    Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    DRX Revolution Mobile X-Ray System

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

    Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026