BEUDAMED
    12 results · 34ms · Sources: EU EUDAMED, US FDA

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    POLI-MAK II

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Mini Twin

    FDA UDI
    Rmo, Inc.·00885797652751·MBT MINI LP 022 HK/345 0T CUSPID 5-5 20EA

    Oph.Spoon

    FDA UDI
    KATENA PRODUCTS, INC.·00841668119976·Bunge Evisceration Spoon, Large 11mm cup

    Pediatric Forceps - #44 Lower Anterior

    FDA UDI
    Denovo Dental, Inc.·00810059291904·Pediatric Forceps - #44 Lower Anterior

    Bioplate®

    FDA UDI
    Bioplate, Inc.·M3848131020·Screwdriver Large - ø1.9mm

    ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING

    FDA 510(k)
    FDA Class 2 ·Radiology

    WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    GORE® DRYSEAL SHEATH

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code DYB·May 15, 2014

    CONCERTO II CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·October 31, 2012

    DELTA

    FDA Adverse Event
    Malfunction ·DRAGER MEDICAL SYSTEMS, INC. (IT/M)·Product code MHX·August 18, 2010

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    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