BEUDAMED
    12 results · 19ms · Sources: EU EUDAMED, US FDA

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    EVOLUTION MP ADAPTIVE CS INSERT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517636171·CoRoent Ant TLIF PEEK, 11x13x32mm 15°

    Bioseal Inc.

    FDA UDI
    BIOSEAL·00630094011332·Bias Stockinette

    POINT 4 FLOWABLE 2

    FDA 510(k)
    FDA Class 2 ·Dental

    IDS-ISYS INTACT PTH

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ENDURON 10D 52OD X 28ID

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code HRY·May 15, 2013

    ARTICULEZE M HEAD 36MM +5

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code JDI·May 20, 2011

    PIC

    FDA Adverse Event
    Malfunction ·WELCH ALLYN PROTOCOL, INC.·Product code MKJ·August 12, 2008

    Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545 Seizach Distributed in the USA by Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The use of external devices provides the surgeon with a means of bone fixation for the management of fracture and reconstructive surgery. These devices are intended only to assist healing and are not intended to replace normal bone structures. External fixation devices are intended to hold fractured bone surfaces in apposition to facilitate normal healing. While proven successful, the devices are manufactured from metal, plastic, and composite materials. No such fracture fixation device, subject to fatigue, can be expected to withstand activity levels in the same way as would a normal health bone. The external fixation system, therefore, will not be as strong, reliable or durable as a normal human bone.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·November 14, 2012

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L231, PROPONENT DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

    FDA Enforcement
    Class II ·Ongoing·Abbott Medical·January 1, 2025