BEUDAMED
    16 results · 20ms · Sources: EU EUDAMED, US FDA

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    HEMODIALYSIS BLOOD LINES

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

    ReLine

    FDA UDI
    Nuvasive, Inc.·00195377068187·RELINE C Conn,3.5-4/5-6mm Clsd Parl

    Instruments

    FDA UDI
    Nuvasive, Inc.·00887517385109·ALGI Curette, Up Angled Large

    i-ED COIL

    FDA UDI
    KANEKA CORPORATION·04540778176584·The i-ED COIL is used for vascular embolization...

    Peerless Buccal Tube

    FDA UDI
    ORMCO CORPORATION·00889989022636·PEERLESS 0DEG SGLLFM-27TRQX018 LR

    Master Series

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746094736·DB BRACKET MASTER SERIES MAND 1ST BICUSPID 5MM ...

    FlexCath Cross Transseptal Solution

    FDA UDI
    ACUTUS MEDICAL, INC.·00850027837864·FlexCath Cross Transseptal Solution– MH 63cm

    Intervertebral Body Fusion Device

    FDA UDI
    PRECISION SPINE, INC.·00840019923286·TLIF Sizer 6mm x 24mm

    PINNACLE ACETABULAR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ARAGON SURGICAL RF SYSTEM L2 INSTRUMENT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ART PILLOW 8MM PUMP SEGM UNIVE

    FDA Adverse Event
    Malfunction ·ERIKA DE REYNOSA·Product code FJK·February 11, 1999

    CVC SET: 2-LUMEN 8FR X 20CM

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code FOZ·May 2, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·November 16, 2010

    SCREW

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·January 7, 2013

    SMR GLENOID PEG TT SMALL-R #L

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code KWS·October 5, 2020

    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