BEUDAMED
    17 results · 21ms · Sources: EU EUDAMED, US FDA

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    LION SE ONE STEP ORTHODONTIC ADHESIVE

    FDA 510(k)
    FDA Class 2 ·Dental

    Hillrom™

    FDA UDI
    Baxter Medical Systems GmbH + Co. KG·00887761976047·Trumpf Medical/Medizin Pad leg section one part...

    Pads

    FDA UDI
    Baxter Medical Systems GmbH + Co. KG·00887761968981·Pad leg section one part short G

    MEDTRONIC MODEL 7499 EXTENSION

    FDA 510(k)
    FDA Class 2 ·Neurology

    PRECISE NITINOL STENT TRANSHEPATIC BILLARY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Panama™

    FDA UDI
    FLOSPINE LLC·B1830804450160·Self Tapping Rescue Fixed Screw, 4.5x16mm

    Panama™

    FDA UDI
    FLOSPINE LLC·B1830804450120·Self Tapping Rescue Fixed Screw, 4.5x12mm

    Panama™

    FDA UDI
    FLOSPINE LLC·B1830804450180·Self Tapping Rescue Fixed Screw, 4.5x18mm

    Panama™

    FDA UDI
    FLOSPINE LLC·B1830805450160·Self Drilling Rescue Bicortical Variable Screw,...

    Panama™

    FDA UDI
    FLOSPINE LLC·B1830804450200·Self Tapping Rescue Fixed Screw, 4.5x20mm

    Panama™

    FDA UDI
    FLOSPINE LLC·B1830804450140·Self Tapping Rescue Fixed Screw, 4.5x14mm

    ALIGN R URETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (COVINGTON) -1018233·Product code FTL·April 24, 2013

    PENUMBRA SYSTEM

    FDA Adverse Event
    Injury ·PENUMBRA, INC.·Product code NRY·April 22, 2011

    ENDOPATH DEXTRUS SEAL CAP ASSEMBLY WITH ACCESSORIES

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GCJ·July 24, 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

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014