BEUDAMED
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    REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517596918·CoRoent Large MP Ti, 15x9x23mm 4°

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526189720·LEVAMED ACTIVE ANKLE SUP BLACK L III

    MILLENNIUM

    FDA UDI
    Avalign Technologies, Inc.·00190776348960·Cushing Vein Retractor

    ULTIMA METAL-ON-METAL ACETABULAR CUP

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL BPW138

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    REMB SAG SAW

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HBE·April 10, 2013

    I-STAT CTNI CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE INC.·Product code MMI·May 23, 2008

    SPRINT QUATTRO SECURE

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

    ReliOn Insulin Syringe 0.5cc 30 Gauge 5/16 inch (8mm) Needle (U-100 Insulin). NDC 81306-0515-23.

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code FMF·October 22, 2004

    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 REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

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

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014