BEUDAMED
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    STRUCTUR 2

    FDA 510(k)
    FDA Class 2 ·Dental

    Bioseal Inc.

    FDA UDI
    BIOSEAL·00630094194110·BIG O Sponge GREEN

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515246256·St. Claire Thompson Adenoid Fcps, 7 1/4"

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471150720·K-WIRE - SINGLE TROCAR 1.1mm DIA x 100mm

    IRRIGATION TUBING SET 2.2M AND 3.8M

    FDA 510(k)
    FDA Class 1 ·Dental

    SPIRAL FLOW VASCULAR ARTERIOVENOUS GRAFT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EXTENSION SET 30IN

    FDA Adverse Event
    Malfunction ·HOSPIRA INC.·Product code FPA·June 3, 2009

    SPIROBAC FILTER REINF MEMBRANE

    FDA Adverse Event
    Malfunction ·COVIDIEN/FORMERLY TYCO HEALTHCARE·Product code CAH·August 1, 2012

    APM/AIM PUMP SET W/C

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·September 28, 2010

    CATH LAB TRAY

    FDA Adverse Event
    Malfunction ·DEROYAL INDUSTRIES·Product code KDD·April 25, 2014

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·January 16, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 22, 2010

    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    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