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

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    HP-20, 30, 40, 50 & 60

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ReLine

    FDA UDI
    Nuvasive, Inc.·00195377020871·RELINE-C Ti Rod, 3.5x100mm Straight

    PILLING

    FDA UDI
    TELEFLEX INCORPORATED·24026704204339·

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M930784110030·Bayonet Knot Pusher 6" working length

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690123668·Femoral Posterior Augment Trial, Size 1+, 10mm

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690121282·Femoral Augment Posterior, Size 1+, 10mm

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172971826·

    Steri-Shield

    FDA UDI
    STRYKER CORPORATION·07613327625264·8 Zippered Toga with Peel Away Face Shield

    T7Plus

    FDA UDI
    STRYKER CORPORATION·07613327466027·Zippered Toga with Peel Away Face Shield

    OPTILITE C1 INACTIVATOR KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    NEXGEN POROUS, HA/TCP, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HATCP STEM POR TIB PLT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBH·March 5, 2024

    NATURALYTE

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 13, 2014

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·November 20, 2012

    EQ-5000 EQUATOR CONVECTIVE WARMER

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD, INC.·Product code DWJ·September 16, 2010

    T5 Hytrel Zipper Toga. Product Usage: The togas are intended to provide a barrier between the operating room and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·June 20, 2012

    Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017