BEUDAMED
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    SHILLA GROWTH GUIDANCE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ForPro

    FDA UDI
    Tng Worldwide, Inc.·00672047001304·Black Vinyl Exam Gloves Size Small 100ct

    ORTHOFIX

    FDA UDI
    ORTHOFIX SRL·18059015374520·STANDARD LOCKING SCREW L75.0MM D4.0MM

    Cancellous Screw, Cannulated

    FDA UDI
    I.T.S. GmbH·09120034307904·Cancellous Screw, Cannulated, D=4.0mm, L=50m

    ORTHOFIX

    FDA UDI
    ORTHOFIX SRL·18059015374025·STANDARD LOCKING SCREW L75.0MM D4.0MM STERILE

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694046343·PrimaLIF LLIF PEEK Implant, 7mm X 26mm X 50mm, ...

    BIO-CHEM ANALYZER, MODEL 100

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AUDIT MICROCV ASO LINEARITY SET, MODEL K721M-5

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    GALAXY G3 MINI 2MM X 4CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·May 23, 2022

    INTELLAMAP ORION¿

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code DRF·February 18, 2016

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    UNKNOWN·Product code IKX·October 3, 2014

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 31, 2013

    EPIC II CRITICAL CARE BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·June 15, 2011

    Chart Paper, Thermal, for SDI Astra Touch

    FDA UDI
    A-M SYSTEMS, LLC·00817081025729·Chart Paper, Thermal, for SDI Astra Touch

    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

    Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc. Oncology Systems·May 22, 2013