BEUDAMED
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    THERMAL LIGATING SHEARS

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

    NOVO Health Services, LLC

    FDA UDI
    NOVO HEALTH SERVICES, LLC·00812564032638·Sieve Pack

    ArgenZ HT+ 98x22 D2

    FDA UDI
    ARGEN CORPORATION, THE·D818122086·Dental porcelain/ceramic restoration kit

    FAC-4 - Class B 21 Lawson - 4 Shelf Cabinet

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588620862·FAC-4 - Class B 21 Lawson - 4 Shelf Cabinet

    ELECSYS CA 125 II CALCHECK 5

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    AIM-V (R) MEDIUM, MODEL 087-0112

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 8, 2023

    EXACTECH

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·July 16, 2024

    COLLAPLUG

    FDA Adverse Event
    Injury ·INTEGRA LIFESCIENCES CORP.·Product code LPG·May 16, 2013

    SENSAR

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HQL·September 26, 2014

    SPRINT FIDELIS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 13, 2011

    SAFESHEATH II 9F

    FDA Adverse Event
    Malfunction ·OSCOR INC.·Product code DYB·August 10, 2022

    SOMATOM Edge Plus-Computed tomography system Model 1026700

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·January 19, 2022

    SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021

    SmartPath to dStream for 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023

    Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATOM Force (Model #10742326) SOMATOM Definition As (Model #8098027) SOMATOM Definition Edge (Model #10590000) SOMATOM Definition Flash (Model #10430603) SOMATOM Drive (Model #10431700) SOMATOM Confidence (Model #10590100) SOMATOM Edge Plus (Model #10267000)

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·October 7, 2020

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012