BEUDAMED
    11 results · 27ms · Sources: EU EUDAMED, US FDA

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    PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    3M™ Unitek™

    FDA UDI
    3M COMPANY·30605861028197·3M™ Unitek™ Stainless Steel First Permanent Mol...

    Metalogix

    FDA UDI
    FUSION ORTHOPEDICS, LLC·00840124521407·Smooth Wire Spade Tip 1.8mm

    Peerless Buccal Tube

    FDA UDI
    ORMCO CORPORATION·00889989022667·ASSY ORTHOS CM SGL 15UFM -10X22 UR

    NA

    FDA UDI
    Stryker GmbH·00886385022383·Sigmoid Notch Radial Insert, Large

    BABI*PLUS BUBBLE PAP VALVE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SPECTRA-VRM Q-SWITCHED ND:YAG LASER SYSTEM, SPECTRA-VRM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES·Product code LZG·May 5, 2014

    3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 18MM

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code KTT·January 7, 2013

    MAYFIELD INFINITY SKULL CLAMP

    FDA Adverse Event
    Malfunction ·INTEGRA-OHIO, INC.·Product code HBL·October 25, 2010

    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