BEUDAMED
    9 results · 17ms · Sources: EU EUDAMED, US FDA

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    SAS SALMONELLA H C ANTISERUM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    3M™ Victory Series™

    FDA UDI
    3M UNITEK CORPORATION·00652221115720·3M™ Victory Series™ First Molar Bands, 952-288,...

    VITALOGIK

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CELLGRO

    FDA 510(k)
    FDA Class 1 ·Hematology

    HEARTSTART MRX-EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 13, 2014

    SUREFIX

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·February 9, 2013

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVY·January 7, 2011

    Arobella Medical 6mm Qurette used with the Arobella Medical AR1000 Wound Therapy System. Major components of the AR1000 Wound Therapy System include an ultrasonic generator, converter hand piece, done-shaped applicator tip (qurette), and a saline supply reservoir. Product Usage: The Arobella Medical AR1000 Wound Therapy System is interned for the selective dissection and fragmentation of tissue, wound debridement ( of acute and chronic wounds, burns, and diseased or necrotic tissue), and cleansing irrigation of the wound site for the removal of debris, exudates, fragments, and other matter.

    FDA Recall
    Terminated ·Arobella Medical, LLC·Product code LFL·November 5, 2012

    Zeiss brand IOLMaster, Version 1-5, 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