BEUDAMED
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    TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ORTHOFIX

    FDA UDI
    ORTHOFIX SRL·18059015374537·STANDARD LOCKING SCREW L77.5MM D4.0MM

    Sterile ACIF PEEK

    FDA UDI
    Tyber Medical, LLC·M6958101407750·ACIF o 14mm x 7mm x 7.5 deg PEEK Curved

    ORTHOFIX

    FDA UDI
    ORTHOFIX SRL·18059015374032·STANDARD LOCKING SCREW L77.5MM D4.0MM STERILE

    LIFEPAK 12

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    BD INTIMA II CLOSED IV CATHETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEPTH GAUGE FOR SMALL SCREWS

    FDA Adverse Event
    Malfunction ·SYNTHES OBERDORF·Product code HTJ·October 3, 2014

    UNKNOWN IV CATHETER

    FDA Adverse Event
    Injury ·BD (SUZHOU)·Product code FOZ·January 13, 2016

    12.0MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code HTO·October 3, 2014

    MECHANICAL CHAIR/TRANSPORT CHAIR

    FDA Adverse Event
    UNKNOWN·Product code INM·May 31, 2013

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·May 31, 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

    C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·September 24, 2014

    C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·December 11, 2013