BEUDAMED
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    PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AND M1193T

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Baltic Denture System BD Load

    FDA UDI
    Merz Dental GmbH·D7091032979·Baltic Denture System BDLoad ↓ Lm6 PLSEum4DFl C...

    COMPRESSIBLE LIMB SLEEVE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LAPARETTE, MODEL LAP J L S H N

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

    X-PEDION HYDROPHYLIC GUIDEWIRE

    FDA Adverse Event
    Malfunction ·EV3 NEUROVASCULAR·Product code DQX·April 3, 2013

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·August 25, 2014

    V60 VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code MNT·March 29, 2011

    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·June 24, 2020

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013