BEUDAMED
    23 results · 22ms · Sources: EU EUDAMED, US FDA

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    TRACHEOSCOPIC VENTILATION TUBE (TVT)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PMMA disc

    FDA UDI
    Dentsply International Inc.·D00180824200·

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X0824200·8mm H x 24mm W x 20mm L x 0 degrees XLIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587L082420120·8mm H x 24mm W x 20mm L XLIF Trial 12 degree Lo...

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X08242080·8mm H x 24mm W x 20mm L x 8 degrees XLIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X082420120·8mm H x 24mm W x 20mm L x 12 degrees XLIF

    HITACHI ALTAIRE

    FDA 510(k)
    FDA Class 2 ·Radiology

    MICRUS STRETCH-RESISTANT MICROCOIL SYSTEM, MSR01

    FDA 510(k)
    FDA Class 2 ·Neurology

    WAVEWRITER ALPHA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 1, 2024

    MALLINCKRODT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code JOH·November 18, 2010

    MALLINCKRODT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code BTR·December 9, 2010

    MALLINCKRODT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code BTR·February 1, 2011

    NEEVA BABY FETAL DOPPLER

    FDA Adverse Event
    Injury ·CONTEC MEDICAL SYSTEM CO., LTD.·Product code KNG·October 27, 2020

    SONOLINE B (FETAL DOPPLER)

    FDA Adverse Event
    Injury ·BABY DOPPLER / DAGAMMA INC.·Product code HGM·January 17, 2019

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 29, 2013

    LIGACLIP EXTRA TITANIUM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·May 9, 2011

    OFFSET ADAPTER 8MM

    FDA Adverse Event
    Malfunction ·STRYKER OTHOPAEDICS LIMERICK·Product code HSH·July 21, 2008

    Zeiss brand IOLMaster 500, Model 500, 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

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for 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.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015