BEUDAMED
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    EXACTECH OPTETRAK PROXIMAL TIBIAL SPACER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACCU-CHEK ACTIVE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT

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

    COCR FEMORAL HEAD

    FDA Adverse Event
    Injury ·ZIMMER MANUFACTURING B.V.·Product code LPH·February 23, 2018

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code MEB·August 23, 2021

    CE INFUSOR LV 2, 12 PACK

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 14, 2010

    CAPSUREFIX

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·April 22, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 12, 2014

    DUROM US ACETABULAR COMPONENT 58/52 R

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·April 13, 2011

    CE INFUSOR SV 2, 12 PACK

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·March 10, 2010

    CT EXPRES

    FDA Adverse Event
    Injury ·BRACCO INJENEERING S.A.·Product code IZQ·September 27, 2023

    Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·October 7, 2020

    Zeiss brand IOLMaster 500, Model 500, 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

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for 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.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024