BEUDAMED
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    DAVOL PAPILLITOME

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

    DD cubeY® HL

    FDA UDI
    Dental Direkt GmbH·EDDIG8450151·The DD cubeY® HL zirconium dioxide milling blan...

    Plateau-X Spacer System

    FDA UDI
    Life Spine, Inc.·00190837012236·

    JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW

    FDA UDI
    OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955932472·Percutaneous Transluminal Angioplasty Balloon C...

    JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW

    FDA UDI
    OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955930270·Percutaneous Transluminal Angioplasty Balloon C...

    JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW

    FDA UDI
    OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955931376·Percutaneous Transluminal Angioplasty Balloon C...

    Plateau-X Spacer System

    FDA UDI
    Life Spine, Inc.·00190837012281·

    dentaform®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011845015000·dentaform® Bands Central Upper right No. 15

    SWIVEL ADAPTOR W/ALARM PORT

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    ACID FAST BACILLI STAIN CONTROL

    FDA 510(k)
    FDA Class 1 ·Microbiology

    VerSys®

    FDA UDI
    Zimmer, Inc.·00889024366671·

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·October 24, 2012

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 20, 2014

    HOSPIRA LIFESHIELD SYMBIQ 150 ML BURETTE SET

    FDA Adverse Event
    Malfunction ·HOSPIRA·Product code FPA·September 22, 2010

    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