BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

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    MULITPLE MALE LATX CONDOM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    1 ML BD¿ SLIP-TIP BARREL WITH SCALE & SILICONE, BULK, NON-STERILE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 6, 2017

    GE LOGIQ 700

    FDA 510(k)
    FDA Class 2 ·Radiology

    BAUMER FEMORAL HEAD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OLYMPUS HF RESECTION ELECTRODES

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code FAS·February 15, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·February 16, 2011

    PULSE GEN MODEL 102R

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·February 26, 2008

    TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code LZD·August 26, 2014

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012

    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·February 5, 2014

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024