BEUDAMED
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    Micro C Medical Imaging System, M01

    FDA 510(k)
    FDA Class 2 ·Radiology

    Bernafon

    FDA UDI
    Bernafon AG·05711584114742·CZ5 MNR T, 2.4G NFM SABE DEMO CORAL 5 GPL

    INTERLINK EXTENSION SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP.·Product code FPA·July 19, 2000

    HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FLOWTRON DVT SLEEVE MODELS DVT10, DVT 20, DVT 30, DVT 40

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    POWDERFREE POLYISOPRENE SURGICAL GLOVES

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

    SIGN I.M. NAIL

    FDA Adverse Event
    Injury ·SURGICAL IMPLANT GENERATION NETWORK (SIGN)·Product code HSB·October 24, 2008

    KINETRA

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·August 11, 2011

    COGNIS

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 9, 2013

    HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201 with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels.

    FDA Enforcement
    Class II ·Terminated·HemoCue AB·September 18, 2013

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 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