BEUDAMED
    15 results · 26ms · Sources: EU EUDAMED, US FDA

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    QUICKIE P300 WHEELCHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    VuePoint

    FDA UDI
    Nuvasive, Inc.·00887517171856·VP Universal Handle, Taps/Drills

    ReLine

    FDA UDI
    Nuvasive, Inc.·00195377092847·RELINE C Conn,3.5-4/4.5-5mm Rot Top-Side

    Sodium Chloride Inhalation Solution, USP 3%

    FDA UDI
    NEPHRON PHARMACEUTICALS·00304879003309·

    Apex

    FDA UDI
    ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529584429·Apex Tibial Nail Ø 9.0 x 330mm

    Orthopedic Instruments

    FDA UDI
    GM DOS REIS INDUSTRIA E COMERCIO LTDA·07899258662053·

    DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR), POWDER FREE, NON STERILE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.16MM

    FDA Adverse Event
    Injury ·LIMACORPORATE SPA·Product code HSD·November 23, 2020

    ENDURANT II

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·June 27, 2014

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·January 7, 2013

    HEARTSTRING III PROXIMAL SEAL SYSTEM, 3.8 MM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code DXC·October 26, 2010

    Superstat Modified Collagen Hemostatic Sponge, 7.5mm x 19mm Cone, 3.0%, Part# 9015-30, 9003-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques

    FDA Enforcement
    Class II ·Terminated·Superstat Corp·November 28, 2012

    Superstat Modified Collagen Hemostatic Sponge, 7.5mm x 19mm Cone, 3.0%, Part# 9015-30, 9003-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques

    FDA Recall
    Terminated ·Superstat Corp·Product code LMF·October 24, 2012

    Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013