BEUDAMED
    11 results · 28ms · Sources: EU EUDAMED, US FDA

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    SPIRO-LINK REAL TIME SPIROMETRY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Vyaire

    FDA UDI
    Jaeger Medical GmbH·14250892903023·Nose clip pad

    Jaeger

    FDA UDI
    Jaeger Medical GmbH·14250892901111·Pad for Nose Clip Qty: 1 Pack of 100

    Jaeger

    FDA UDI
    Jaeger Medical GmbH·14250892907021·Nose clip pad

    Black Diamond Pedicle Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AEROBITRON III

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    NC TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·June 24, 2014

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LNQ·January 2, 2013

    PROLIFT PELVIC FLOOR REPAIR

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·November 3, 2010

    GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 29, 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