BEUDAMED
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    PURGE LINE UNIT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Coblation

    FDA UDI
    Smith & Nephew, Inc.·00817470001419·PERC DC (OLD)

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065708·INTRAORAL ELASTICS 4,5 oz 1/4" red

    NASAL AIRE II PEDIATRIC, MODEL 5 SIZES, MODEL TBD

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HydroCision TenJet Device

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿

    FDA Adverse Event
    Death ·ST. JUDE MEDICAL·Product code OAE·August 9, 2023

    TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code OAE·August 9, 2023

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·May 5, 2014

    PROTECTA XT VR

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code NIK·October 15, 2012

    CE INTERMATE LV 250, 24 PACK,50126

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·August 10, 2010

    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

    Promote, Sterile EO, Model #/ Part #: 3207-30/60010740-207, 60010740-407; 3207-36/60010743-207, 60010743-407; 3213-36/50022126-001, 60013879-307, 60013879-407, 60013879-707; CD3211-36/100006984,100012548, 100012550, 100016680, 100031621, 100035618, 100035619, 100042487, 100047194; CD3211-36Q/100004091, 100004093,100019784, 100035620, 100042486, 100047054; CD3215-36/100006995, 100010246, 100010247, 100010249, 100010250, 100012569, 100012570, 100034981, 100046577, 100046802, 60019065; CD3215-36Q/100004059, 100004060, 100004061, 100023304, 100030590, 100033678, 100042492, 100046803, 100046906

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018