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

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    JR MEDIC

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517569899·CoRoent Ant TLIF Ti, 12x12x34mm 8°

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113370·CLEAR CORNEA KNIFE 3.2MM (BX/5)

    QUARTZ SPLINT SYSTEM (UD, WOVEN, ROPE, MESH) QUARTZ SPINT RESIN QS FLOW

    FDA 510(k)
    FDA Class 2 ·Dental

    ACCESS CONCENTRATION SYSTEM, MODEL ACC-100, ACCESS DISPOSABLE SET, MODEL ADS-2000

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OT ULTRALINK METER

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

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

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

    MLRY-HD LAT POR FMRL 13MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LPH·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

    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