BEUDAMED
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    FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694003568·Left Reconstruction Plate w/Angle

    OIC Sliding Hip Screw (SHS) System

    FDA UDI
    ORTHOPAEDIC IMPLANT COMPANY, THE·10811998032532·SLIDING HIP SCREW PLATE, 140 DEGREE, 3 HOLE, ST...

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319754726·Ochsner-baby forceps, straight, extra delicate,...

    OIC Sliding Hip Screw (SHS) System

    FDA UDI
    ORTHOPAEDIC IMPLANT COMPANY, THE·M696SHS1400620·SLIDING HIP SCREW PLATE, 140 DEGREE, 3 HOLE, ST...

    Restore

    FDA UDI
    KEYSTONE DENTAL, INC.·D768L14006223K0·Hex Driver

    Restore

    FDA UDI
    KEYSTONE DENTAL, INC.·D768L14006219K0·Hex Driver

    INFILTRATION KIT

    FDA 510(k)
    FDA Class 2 ·Dental

    LEVIA PHOTOTHERAPY SYSTEM

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

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·August 26, 2019

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·February 6, 2019

    COGNIS

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 3, 2014

    AUTOPULSE NIMH BATTERY

    FDA Adverse Event
    Death ·ZOLL CIRCULATION, INC.·Product code DRM·May 20, 2013

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·June 25, 2011

    EQUINOXE SHOULDER COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWS·January 9, 2024

    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

    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