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

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    RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    JOBST SensiFoot

    FDA UDI
    BSN MEDICAL, INC.·00035664108465·SENSIFOOT 8-15 MM HG CREW SMALL NAVY 1 EN FR ES

    Leva® Anterior Interbody System

    FDA UDI
    Spine Wave, Inc.·10840642108910·Plate, 38 mm (W) x 15 mm (H)

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306819018·Double Hook malleable retractor w/Simpson Handl...

    COMFORT TOUCH INSUIN PEN NEEDLES

    FDA Adverse Event
    Malfunction ·JIANGSU CAINA TECHNOLOGY CO., LTD.·Product code FMI·May 21, 2021

    SIMPLICITY SILVER SET SOFT INFUSION

    FDA 510(k)
    FDA Class 2 ·General Hospital

    IMC SURGICAL FACE MASK

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ARTERIAL PRESSURE MONITORING TRAY

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQO·December 3, 2024

    UNKNOWN DEPUY ACETABULAR CUP

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·May 14, 2013

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·June 2, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 14, 2008

    REVITAN, RASP, DISTAL, CURVED, 14/140

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code JDI·April 11, 2018

    DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dural defects and as an adhesion barrier for the reduction of peridural fibrosis. DuraGen Plus matrix is an easy to handle, soft, white pliable, non-friable, porous, collagen matrix. DuraGen Plus matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corporation·May 22, 2013

    Video Duodenoscope

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·June 8, 2016

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024