BEUDAMED
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    FUJI SYNAPSE WORKSTATION SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACUMATCH GXL 15DEG LINER 36MM SZ J

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·April 19, 2024

    SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BREAS PV 100 CPAP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ELECTRODE, PACEMAKER, PERMANENT

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·April 10, 2013

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·April 12, 2011

    VICRYL PLUS ANTIBACTERIAL SUTURE

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code GAM·May 16, 2008

    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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024