BEUDAMED
    27 results · 23ms · Sources: EU EUDAMED, US FDA

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

    VANGUARD REMOVABLE MOLDED POLY TIBIA

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COLLAGEN WOUND DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    QUICK-SET PARADIGM INFUSION SET

    FDA Adverse Event
    Death ·UNOMEDICAL A/S·Product code FPA·February 10, 2017

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 27, 2024

    V.A.C. THERAPY

    FDA Adverse Event
    Injury ·KCI USA INC.·Product code OMP·June 5, 2013

    MAYFIELD 200 RADIOLUCENT SKULL CLAMP

    FDA Adverse Event
    Injury ·INTEGRA LIFESCIENCES CORPORATION OH/USA·Product code HBL·September 8, 2014

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 27, 2011

    OHICHO3

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·August 30, 2022

    OHICHO3

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·March 18, 2026

    METACROSS OTW PTA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·August 19, 2019

    OHICHO NEO

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·February 7, 2024

    OHICHO3

    FDA Adverse Event
    Injury ·Product code LIT·December 26, 2019

    SHIRANUI EX

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·August 12, 2020

    OHICHO3

    FDA Adverse Event
    Injury ·Product code LIT·July 19, 2019

    INTERA 3000

    FDA Adverse Event
    Injury ·INTERA ONCOLOGY·Product code LKK·April 23, 2025

    Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter with Obturator Product Code: PEB623 Sure-Pro¿ Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra¿ Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure, the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure, the clinician places the outer sheath through the cervical canal into the uterus, then loads the embryo in the inner catheter, and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·May 15, 2013

    PTA BALLOON CATHETER(OHICHO3)

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·December 13, 2017

    SHIRANUI EX

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·August 14, 2020

    SHIRANUI EX

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·September 30, 2020