BEUDAMED
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    PACIFIER THERMOMETER MODELS VT-901F, VT901C

    FDA 510(k)
    FDA Class 2 ·General Hospital

    RMO

    FDA UDI
    Rmo, Inc.·00885797099747·LING RETNR BD 3X3 6 CS WO/INST

    Creation Willi Geller

    FDA UDI
    KLEMA Dentalprodukte GmbH·ECWG0025621·CC/ Enamel S-058

    NEURO SCAN MEDICAL SYSTEMS A4000

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SAMSUNG 10DR IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    LUMA ARCH

    FDA Adverse Event
    Injury ·LUMALITE, INC.·Product code EEG·July 6, 2004

    FEMORAL STEM PRESS-FIT COLLARLESS 12/14TAPER EXTENDED NECK OFFSET SIZE 12 128 MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·January 30, 2020

    AIR DERMATOME HANDPIECE

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL·Product code GFA·June 10, 2014

    ACCUTORR PLUS

    FDA Adverse Event
    Malfunction ·MIDRAY DS USA, INC.·Product code MHX·January 28, 2011

    SEQUOIA

    FDA Adverse Event
    Injury ·ABBOTT SPINE, INC.·Product code KWP·February 26, 2008

    bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    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