BEUDAMED
    17 results · 20ms · Sources: EU EUDAMED, US FDA

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    SYNTHES 4.5 MM LCP POSTEROLATERAL PROXIMAL FEMUR PLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Paltop

    FDA UDI
    PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108694031·Step Drill Stop for L8mm Implant, Wide Long

    Paltop

    FDA UDI
    PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108697650·Titanium Base Abutment Round, Int. Hex. SP L4mm...

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345023918·PADDLE SPREADER, 8MM

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0102080·Shaver, Open 8mm

    AutoPulse Battery

    FDA UDI
    Zoll Circulation, Inc.·00849111002066·Box containing Nickel-metal Hydride (NiMH) batt...

    DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GLUCOMETER ELITE DIABETES CARE SYSTEM (MODIFIED)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    LUX 1440

    FDA Adverse Event
    Malfunction ·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012

    NEOPUFF INFANT RESUSCITATOR

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTL·November 27, 2013

    XVI

    FDA Adverse Event
    Other ·ELEKTA LTD.·Product code IYE·April 16, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·April 18, 2011

    AFFINITY 4

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code HDD·June 30, 2008

    BABY CONTROL MOBILE INFANT WARMER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code FMT·June 17, 2012

    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 System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020