BEUDAMED
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    MEDILASE 5010 ENDOSCOPE CONSOLE

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

    HTH®-Right 16mm

    FDA UDI
    SPECIALTY APPLIANCES, LLC·D8199003800·

    Apex

    FDA UDI
    ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529587819·Apex Femoral Nail Retrograde Ø 9.0 x 380mm

    SOMATEX

    FDA UDI
    BIOPSYBELL SRL·08033860021597·

    MOBILE LINER INT 28 MM 42 MM

    FDA Adverse Event
    Injury ·LIMACORPORATE SPA·Product code LZO·July 14, 2020

    MAGNUM M FIXATION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FOTOMASTER

    FDA 510(k)
    FDA Class 2 ·Radiology

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 21, 2020

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/10 MM L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 27, 2021

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·March 30, 2020

    CASSETTE MEDI RESERVOIR

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FRN·March 5, 2020

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code FPA·June 27, 2014

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·January 7, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·November 16, 2010

    GMK PRIMARY TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 17, 2025

    SMR GLENOID PEG TT SMALL-R #L

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code KWS·October 5, 2020

    SMR HUMERAL HEAD Ø44 MM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code KWT·May 23, 2022

    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