BEUDAMED
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    FACTOR XII DEFICIENT PLASMA

    FDA 510(k)
    FDA Class 2 ·Hematology

    ReLine

    FDA UDI
    Nuvasive, Inc.·00195377068354·RELINE C Screw, 4.5x12mm Occipital

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517385574·CoRoent XL Trial, 12x18x55mm

    Prehma

    FDA UDI
    Keystone Industries·H66819004121·MATRIX T-BAND LG X100 ( BAG X 100 )

    Para-Pak 10% Formalin Fixative

    FDA UDI
    MERIDIAN BIOSCIENCE, INC.·00840733101908·Para-Pak based systems provide standardized pro...

    Para-Pak 10% Formalin Fixative

    FDA UDI
    MERIDIAN BIOSCIENCE, INC.·00840733102707·Para-Pak based systems provide standardized pro...

    SOMATEX

    FDA UDI
    BIOPSYBELL SRL·08033860021757·

    POWDER FREE NITRILE EXAMINATION GLOVES (PINK, GREEN, ORANGE,WHITE).

    FDA 510(k)
    FDA Class 1 ·General Hospital

    VISION R/F TILTING TABLE

    FDA 510(k)
    FDA Class 2 ·Radiology

    Intervertebral Body Fusion Device

    FDA UDI
    PRECISION SPINE, INC.·00840019923545·PLIF Sizer 12mm x 22mm

    TCP

    FDA UDI
    WRIGHT MEDICAL TECHNOLOGY, INC.·00840420118516·

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    FDA Adverse Event
    Death ·AV-TEMECULA-CT·Product code MAF·June 27, 2014

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 26, 2010

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·January 7, 2013

    STEALTHSTATION¿ S8 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·April 1, 2024

    OPTETRAK Comprehensive Knee System custom devices labeled as the following: a. CUSTOM OPTETRAK ANGLED PS INSERT (Product Line: 900-06-XX, 900-08-XX); b. CUSTOM OPTETRAK CC TIBIAL INSERT (Product Line: 900-23-XX, 900-30-XX); c. CUSTOM OPTETRAK CC INSERT (Product Line: 900-33-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    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