BEUDAMED
    14 results · 21ms · Sources: EU EUDAMED, US FDA

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    OMNIPRO SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    Cook

    FDA UDI
    COOK INCORPORATED·00827002145306·Connecting Tube

    MedGyn Pessary Dish w/support # 6

    FDA UDI
    MEDGYN PRODUCTS, INC.·M803050143·Dish Pessary is used to treat uterine prolapse.

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450454459·

    MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERED

    FDA 510(k)
    FDA Class 1 ·General Hospital

    VASOVIEW 5 HARVESTING CANNULA

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PROGRASP FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·August 21, 2014

    DEPUY ARTICUL/EZE METAL ON METAL FEMORAL HEAD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC·Product code JDI·March 15, 2013

    CAPTURE R READY ID EXTEND

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·May 27, 2008

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 1, 2011

    TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·April 29, 2022

    CELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II¿ is a semi-automated fluorescence microscope, consisting of the analyzer, a dedicated computer with CELLTRACKS¿ software, monitor, keyboard, mouse and uninterruptible power supply (UPS). The system also supports an optional Remote Review Workstation (RRW), which consists of a dedicated computer with CELLTRACKS¿ software, monitor, keyboard and mouse. Use of this product requires training and should be used under the supervision of laboratory management. The CELLTRACKS ANALYZER II¿ is for analysis of rare cells that are isolated from biological fluids including whole blood. It is used in conjunction with the CELLTRACKS¿ AUTOPREP¿ System, which automates and standardizes the sample preparation with specific reagent kits. An optional Remote Review Workstation is also available to provide the capability to review images and report results remotely.

    FDA Enforcement
    Class II ·Terminated·Veridex, LLC·March 19, 2014

    WASP (Walk Away Specimen Process). Automatic Planting and Streaking Instrument Catalog number: W086 WASP is a fully automated system used to process microbiological specimens in liquid phase for the investigation of infectious microbes.

    FDA Enforcement
    Class III ·Terminated·Copan Italia·September 11, 2013

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

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