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

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    PHARMASEAL WOUND IRRIGATION DEVICE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556704780·GC Initial™ AL Dentin DA2, 20g

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228740221·GC Initial™ Ti Powder Opaque Mod. OM-6, 20g

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867523661·Spine Compression Screw, 4.0x22mm

    PVP IODINE

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ELECATH VENTRICULAR PACING THERMAL DILUTION CATH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES·Product code LZG·June 5, 2014

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·October 19, 2010

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·December 14, 2012

    Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part number 03.010.048) and the Thumb Screw for the Aiming Arm for Titanium Cannulated Tibial Nails-EX (part number 03.010.052). The Recon Locking Aiming Arm for Lateral Entry Femoral Recon Nails- EX is used when locking the Femoral Nail-EX. The Aiming Arm for Titanium (TI) Cannulated Tibial Nails-EX is used when locking the Tibial Nail-EX.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·March 25, 2015

    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