BEUDAMED
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    Exofin Fusion Skin Closure System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BD DIRECTIGEN EX FLU A+B

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 21, 2014

    BONE SCREW, CROSS-PIN, DIAM.2.3X10MM, STERILE, (1/PACKAGE)

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS-FREIBURG·Product code JEY·June 26, 2013

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code DRY·June 7, 2011

    BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·July 17, 2019

    BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·June 21, 2019

    BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE: POTASSIUM OXALATE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·June 25, 2019

    BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE: POTASSIUM OXALATE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·June 18, 2019

    BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·June 12, 2019

    BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE: POTASSIUM OXALATE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·June 18, 2019

    BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE: POTASSIUM OXALATE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·June 18, 2019

    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

    Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

    FDA Enforcement
    Class I ·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024