BEUDAMED
    13 results · 18ms · Sources: EU EUDAMED, US FDA

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    PTT-LT TEST KIT

    FDA 510(k)
    FDA Class 2 ·Hematology

    Alexander SpiritMB

    FDA UDI
    ORMCO CORPORATION·00889989007145·ID F - Twin - Upper-Right Lateral-Hook - Red

    Ophthalmic Scissors

    FDA UDI
    KATENA PRODUCTS, INC.·00841668105108·TROUTMAN-CASTROVIEJO SCISSORS LEFT

    RAPID Graft Delivery

    FDA UDI
    Seaspine Orthopedics Corporation·10889981143053·Circular Funnel Pusher

    QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS

    FDA 510(k)
    FDA Class 2 ·Immunology

    POWERED WHEELCHAIR, MODEL B-600

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    EXTENSION SET 30IN

    FDA Adverse Event
    Malfunction ·HOSPIRA INC.·Product code FPA·June 3, 2009

    APM/AIM PUMP SET W/C

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·September 28, 2010

    SYMBIQ DUAL CHANNEL

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·January 18, 2013

    REFLEX HYBRID ACP

    FDA Adverse Event
    Malfunction ·STRYKER SPINE·Product code KWQ·December 23, 2010

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 17, 2014

    Spirit MB Brackets, part #494-1210. The brand name of the device is Spirit MB Brackets, an orthodontic bracket. Spirit MB Brackets have been assigned the product code 76 DYW (Plastic Orthodontic Bracket) by the FDA and is classified as a Class II Medical Device. Spirit MB Brackets are to be fixed attachment on a tooth which holds an archwire during orthodontic treatment.

    FDA Recall
    Terminated ·Ormco Corporation·Product code DYW·May 18, 2011

    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