BEUDAMED
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    ACCU-CHEK AVIVA TEST STRIPS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    REMEL

    FDA UDI
    REMEL, INC.·00848838006678·CTA w/1% Maltose (4ml) 20/PK

    Mini-Mono®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR70606201·Mini-Mono-Brackets Roth 'S2' .022" 9° 1000 Brac...

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0606000·Tray, Base, 6"

    ENDOSCOPIC STAPLE REMOVAL INSTRUMENT

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PBN FALLOPIAN TUBE CATHETER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Widex

    FDA UDI
    Widex A/S·05706069794489·Widex EVOKE E-CIC-M TR (Light beige ) 220

    Widex

    FDA UDI
    Widex A/S·05706069794496·Widex EVOKE E-CIC-M TR (Clay brown ) 220

    Widex

    FDA UDI
    Widex A/S·05706069794502·Widex EVOKE E-CIC-M TR (Dark brown ) 220

    HEARTSTART XL + DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 27, 2013

    ASR UNI FEMORAL IMPL SIZE 49

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 6, 2011

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIEC

    FDA Adverse Event
    Injury ·STAAR SURGICAL·Product code HQL·June 13, 2008

    NEOPUFF INFANT RESUSCITATOR

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTL·March 22, 2015

    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