BEUDAMED
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    SPI EASY TEMPORARY CAP

    FDA 510(k)
    FDA Class 2 ·Dental

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496051527·VENERE 30, SIZE XXL, MIELE, GRADUATED COMPRESSI...

    FOTONA FIDELIS ER: YAG LASER SYSTEM AND ACCESORIES

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

    PRAXSYS RELIA TSH TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FOZ·January 13, 2022

    SPRINT FIDELIS

    FDA Adverse Event
    Malfunction ·MPRI·Product code LWS·April 10, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·January 28, 2011

    I-STAT CTNI CARTRIDGE

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

    ADVANCE 35 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQY·May 7, 2019

    ADVANCE 35 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQY·July 14, 2017

    TRUSTEEL

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·November 26, 2024

    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