BEUDAMED
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    PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CapSure® Spine System

    FDA UDI
    Spine Wave, Inc.·10840642104387·Rod Straight 5.5 x 35mm

    DANmed

    FDA UDI
    DANNORITZER Medizintechnik GmbH & Co. KG·04251351101724·LAP-Instrument, Ø5mm, l=350mm, flushp. Forcep...

    Recon

    FDA UDI
    Revelation Medical Devices·G318101132350·Curved Osteotome

    SMR CEMENTL. REV. STEM Ø13 MM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code KWS·November 12, 2018

    ACCU-CHEK COMFORT CURVE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code CFR·August 12, 2006

    ERBEFLO 2 DISPOSABLE TUBING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MODIFICATION TO SYNCHRON CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 8, 2013

    FRESENIUS 2008K

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·September 2, 2014

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON·Product code FTL·June 3, 2011

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 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