BEUDAMED
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    ATRICURE CRYO MODULE SYSTEM

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

    Gyrus ACMI

    FDA UDI
    Gyrus ACMI, LLC·00821925014053·SHEA TORP PROTHESIS 1 MM SHAFT DIAMETER 7 MM LE...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694003520·28mm 4 Hole Fracture Plate

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776207861·EllikToomey™ Adapter locking

    Merit® Kit

    FDA UDI
    Merit Medical Systems, Inc.·00884450276983·

    POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    BPA-FREE PIT AND FISSURE SEALANT

    FDA 510(k)
    FDA Class 2 ·Dental

    BAROUK SCREW - 3 0MM X 32MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HWC·April 7, 2020

    MPACT ACETABULAR SHELL Ø 52 TWO-HOLES

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·April 28, 2016

    TRILOGY O2

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code CBK·May 29, 2013

    ENDOTAK RELIANCE SG

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code LWS·October 3, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·June 25, 2011

    UNIVERSA LOOP NEPHROSTOMY PERCUTANEOUS DRAINAGE CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code KOB·May 2, 2018

    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