BEUDAMED
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    DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604

    FDA 510(k)
    FDA Class 2 ·Immunology

    Bur PM2-95 80K diamond Ø1.8mm sterile

    FDA UDI
    Bien-Air Surgery SA·J00711003210011·

    Bur PM2-95 80K Diam Ø1.8 St

    FDA UDI
    Bien-Air Surgery SA·17630055502923·

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    FDA UDI
    FX SOLUTIONS·03701037309179·HEX 3.5mm SCREW

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694001977·5mm Pyriform Plate

    MODULAR FOOT SYSTEM - 2.7 MM MODULE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HEMISPHERE MODULAR CUP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·May 8, 2013

    12/14 ARTICUL 40MM M SPEC+1.5

    FDA Adverse Event
    Injury ·8010379 DEPUY INTL., LTD.·Product code JDI·September 18, 2014

    RESTORE ADVANCED RECHARGEABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·May 16, 2011

    PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC.·Product code OMP·July 19, 2019

    OPTILENE 6/0 (0,7) 75CM 2XDRC13 CV2 RCP

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAW·December 9, 2025

    OPTILENE 7/0 (0,5) 60CM 2XDRC8 CV2 RCP

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAW·December 9, 2025

    GMK PRIMARY TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 4, 2025

    PIRANHA

    FDA Adverse Event
    Injury ·RICHARD WOLF GMBH·Product code JCX·January 5, 2022

    Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation

    FDA Enforcement
    Class II ·Terminated·Primus Corporation·November 11, 2020

    Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·October 1, 2025

    Brilliance iCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    TherMax Blood Warmer Unit

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·November 6, 2019

    Brilliance iCT and Brilliance iCT SP These systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. May include signal analysis and display equipment, patient and equipment supports, components and accessories

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 5, 2014