BEUDAMED
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    CRONEX QUANTA SUPER RAPID SR339 RARE EARTH

    FDA 510(k)
    FDA Class 1 ·Radiology

    Bard® CritiCore® Surgipack® with Bardex® LubriCath® Temp Sensing Catheter

    FDA UDI
    C. R. Bard, Inc.·00801741019340·Bard® CritiCore® Surgipak®System with Bardex® L...

    Peerless Buccal Tube

    FDA UDI
    ORMCO CORPORATION·00889989022674·ASSY ORTHOS CM SGL 15UFM -10X18 UR

    CARESTREAM DRX-1 SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    H-MAX S LATERALIZING UNCEMENTED STEMS

    FDA Adverse Event
    Injury ·LIMACORPORATE SPA·Product code MEH·June 6, 2022

    SMR CEMENTLESS FINNED STEM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code HSD·November 4, 2020

    SMR HUMERAL HEAD D.44 H.14MM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code KWT·October 2, 2020

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

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

    ACCU-CHEK ® SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE, INC.·Product code LZG·July 8, 2015

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

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

    SMR HUMERAL HEAD 44 MM

    FDA Adverse Event
    Injury ·LIMACORPORATE SPA·Product code KWT·September 23, 2020

    SMR CEMENTLESS MINI STEM

    FDA Adverse Event
    Injury ·LIMACORPORATE SPA·Product code HSD·June 17, 2020

    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