BEUDAMED
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    SAS SPICER-EDWARDS 1 ANTISERUM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690128854·Revision Fluted Offset Stem 22mm x 100mm x 4mm

    3M™ Victory Series™

    FDA UDI
    3M UNITEK CORPORATION·00652221118189·3M™ Victory Series™ Second Molar Bands, 955-223...

    GUARD

    FDA UDI
    KLS-Martin L.P.·00888118118585·FIBULA

    METAL ENCLOSED SIDE FIRING FIBERS

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

    OCTA-HEX (TM) IMPLANT RESTORATION SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Dental

    Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243

    FDA Enforcement
    Class II ·Ongoing·CORIN MEDICAL, LTD.·July 9, 2025

    GELWEAVE STRAIGHT GRAFT

    FDA Adverse Event
    Injury ·VASCUTEK LTD·Product code DSY·August 10, 2012

    M2A TPR HI CARBON 41/32MM LINER

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWY·February 11, 2013

    ATLAS PLUS VR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·January 10, 2011

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    FDA Adverse Event
    C.T.M. SHANGHAI·Product code INI·July 24, 2014

    Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243

    FDA Recall
    Open, Classified ·CORIN MEDICAL, LTD. Unit 1-57-8 Corinium Centre Cirencester United Kingdom·Product code JWH·May 23, 2025

    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