BEUDAMED
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    JUGGERKNOT MINI SOFT ANCHOR

    FDA 510(k)
    FDA Class 2 ·Dental

    Gyrus ACMI

    FDA UDI
    Gyrus ACMI, LLC·00821925014701·SHEA TORP PROSTHESIS 1 MM SHAFT DIAMETER 5 MM L...

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319720844·Randall Kidney Stone Forceps 7-3/4" (19.4cm), 3...

    UNICEM HM

    FDA 510(k)
    FDA Class 2 ·Dental

    EBI DISTAL RADIUS PLATING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ADULT NASAL INTERFACE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code CAT·January 21, 2016

    TRIDENT ALUMINA INSERT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code MRA·June 3, 2013

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)

    FDA Adverse Event
    Injury ·ALLERGAN·Product code LTI·June 21, 2011

    GE OEC 9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 3, 2008

    TOTAL KNEE REPLACEMENT

    FDA Adverse Event
    Malfunction ·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·November 10, 2016

    PATIENT SPECIFIC TOTAL FEMUR

    FDA Adverse Event
    Injury ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·August 15, 2018

    NOMAD Pro2 Packaged X-Ray System, Part Number 08500021; NOMAD Pro2 Packaged X-Ray System Black, Part Number 08500022; NOMAD Pro2 Vet Packaged X-Ray System, Part Number 08500023; NOMAD Pro2 Vet Packaged X-Ray System Black, Part Number 08500024; NOMAD Pro2 Packaged X-Ray System, GBL, Part Number 08500025 and Part Number 08500026; NOMAD Pro2 Packaged X-Ray System, GLB, Vet, Part Number 08500027 and Part Number 08500028; NOMAD Pro2 Package X-Ray System, GLB, Black, Part Number 08500029

    FDA Enforcement
    Class II ·Terminated·Aribex Inc·September 14, 2016

    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