BEUDAMED
    16 results · 22ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    SMR Shoulder System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Oxford® Partial Knee System

    FDA UDI
    Biomet Uk Ltd·05019279442294·

    CONTOUR TECHNOLOGY MUSCLE STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS06-1

    FDA 510(k)
    FDA Class 2 ·Neurology

    SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LJS·December 19, 2017

    ARTOURA BREAST TISSUE EXPANDER

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code LCJ·March 31, 2020

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 14, 2011

    PENTA

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 5, 2013

    PRECISION LINK

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code NBW·September 11, 2008

    ARTOURA BREAST TISSUE EXPANDER

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code LCJ·May 26, 2022

    ARTOURA BREAST TISSUE EXPANDER

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code LCJ·October 10, 2020

    TURBO-FLO SINGLE LUMEN CENTRAL VENOUS CATHETER SET

    FDA Adverse Event
    Injury ·COOK INC·Product code LJS·October 1, 2018

    TURBO-FLO SINGLE LUMEN CENTRAL VENOUS CATHETER SET

    FDA Adverse Event
    Injury ·COOK INC·Product code LJS·October 1, 2018

    Jackson-Pratt Silicone Round Drain, 10FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·May 31, 2017

    REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEE

    FDA Enforcement
    Class II ·Terminated·Enztec Limited·February 3, 2021

    RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014