BEUDAMED
    12 results · 29ms · Sources: EU EUDAMED, US FDA

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    BIS ENGINE

    FDA 510(k)
    FDA Class 2 ·Neurology

    MINIMED QUICK-SET

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·November 6, 2024

    PROSTHESIS - UNIVERSAL TITANIUM PROSTHESIS

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ETA·February 19, 2016

    PUMA DENTAL CHAIR AND UNIT

    FDA 510(k)
    FDA Class 1 ·Dental

    NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR BLUE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MINIMED QUICK-SET

    FDA Adverse Event
    Injury ·UNOMEDICAL UM-D·Product code FPA·March 8, 2025

    GOBED II

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·March 13, 2013

    UNKNOWN DEPUY PFC TIBIAL TRAY

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·February 16, 2011

    COVIDIEN/KENDALL

    FDA Adverse Event
    Other ·COVIDIAN·Product code LZH·February 21, 2008

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020

    Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018