BEUDAMED
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    HYCULT DIAMOND CORONARY BYPASS KNIFE

    FDA 510(k)
    FDA Class 1 ·Cardiovascular

    MEDFUSION

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code FRN·August 13, 2020

    MODOFICATION TO AFFFINITY 38 MICRO ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB351/CB352

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AVITA NASAL ASPIRATOR, MODEL, NS1 SERIES

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

    CADD

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code FPA·August 13, 2020

    CADD CASSETTE RESERVOIR

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code FPA·August 13, 2020

    CADD

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code FPA·August 13, 2020

    TRI-LOCK BPS SZ 9 HI OFFSET

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.-1818910·Product code KWA·June 27, 2014

    O-ARM 1000 IMAGING SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION·Product code IZL·October 26, 2010

    LIGAMAX-5MM

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·January 7, 2013

    SUPER SHEATH

    FDA Adverse Event
    Injury ·TOGO MEDIKIT CO., LTD.·Product code DRE·September 25, 2024

    SUPER SHEATH

    FDA Adverse Event
    Injury ·TOGO MEDIKIT CO., LTD.·Product code DRE·July 13, 2023

    SUPER SHEATH

    FDA Adverse Event
    Injury ·TOGO MEDIKIT CO., LTD.·Product code DRE·May 23, 2024

    SUPER SHEATH

    FDA Adverse Event
    Injury ·TOGO MEDIKIT CO., LTD.·Product code DRE·June 7, 2024

    SUPER SHEATH

    FDA Adverse Event
    Injury ·TOGO MEDIKIT CO., LTD.·Product code DRE·November 28, 2024

    SUPER SHEATH

    FDA Adverse Event
    Injury ·TOGO MEDIKIT CO., LTD.·Product code DRE·October 31, 2023

    SMR CEMENTLESS FINNED STEM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code HSD·November 7, 2023

    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