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

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    JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Powder Free, White, Blue, Pink, Black Nitrile Synthetic Rubber Examination Gloves

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Cartesion Prime, PCD-1000A, V10.7

    FDA 510(k)
    FDA Class 2 ·Radiology

    LOCKING SCREW, FULLY THREADED 5X35 MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·December 8, 2011

    COLONOVIDEOSCOPE

    FDA Adverse Event
    Malfunction ·AIZU OLYMPUS CO., LTD.·Product code FDF·April 23, 2026

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 4, 2014

    UNICEL® DXC SYNCHRON ® CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·August 25, 2011

    FREESTYLE FREEDOM

    FDA Adverse Event
    Injury ·Product code NBW·July 12, 2013

    Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and CH14/40CM Product Usage: Urinary Catheters are sterile disposable devices intended to provide an intermittent pathway for drainage of fluids from the bladder. They are intended to be inserted intermittently through the urethra and up to the bladder enabling urine to drain. They are designed for short-term, intermittent transient use only and are not intended to be left in situ (there is no balloon on the tip to allow the catheter to be retained within the bladder). They are intended for single use only. They are intended to be removed once the bladder is fully drained. The goal of intermittent catheterization using Urology Catheters is to completely empty the bladder and prevent Urinary Tract Infections (UTIs).

    FDA Enforcement
    Class II ·Ongoing·ConvaTec, Inc·March 27, 2019

    Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021