BEUDAMED
    13 results · 28ms · Sources: EU EUDAMED, US FDA

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    REXIOUS HOOK FIXATION SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517577160·CoRoent Ant TLIF PEEK, 11x13x32mm 4°

    SCREW,FIXATION,BONE

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code HWC·June 9, 2017

    PRECISION LIQUID OXYGEN SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HPI SENSI GRIP STERILE POWDERED LATEX SURGICAL GLOVE,WITH LABELED PROTEIN CONTENT AND MADE FROM ALLOTEX AN ENZYME TREAT

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ULTAMET MTL INS NEUT 36MM 56OD

    FDA Adverse Event
    Injury ·8010379 DEPUY INTL., LTD.·Product code KWA·May 15, 2013

    ALTRX +4 10D 36IDX52OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·May 20, 2011

    TANDEMHEART PUMP

    FDA Adverse Event
    Malfunction ·CARDIACASSIST, INC.·Product code KFM·August 12, 2008

    4.5 BROAD SCP PLT 26-H STER

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES SELZACH·Product code HWC·June 2, 2015

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES SELZACH·Product code HWC·June 3, 2015

    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

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023