BEUDAMED
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    S6 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017729·K-Wire, Double Ended, Trocar Point, Diameter Si...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450862773·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450052341·

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383504157·Gutta Percha Points is used to root canal filin...

    K2M General Instruments

    FDA UDI
    VB Spine LLC·10888857530539·Torque Limiting Handle Size 5 Nm

    GMK-SPHERE TIBIAL INSERT E-CROSS - CR 2R - 10MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 8, 2022

    CAROTID COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    CROSSTEX ISOLITE EARLOOP FACE MASKS-BLUE, PINK, CROSSTEX ISOFLUID EARLOOP FACE MASKS-BLUE, PINK, WHITE, GREEN. CROSSTEX

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

    AQUILEX FLUID CONTROL SYSTEM

    FDA Adverse Event
    Malfunction ·W.O.M. WORLD OF MEDICINE GMBH·Product code HIG·March 12, 2020

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 14, 2013

    TM MULTI HOLE ACETABULAR SHELL

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code KWZ·September 10, 2014

    UNKNOWN DEPUY ASR HIP

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD.·Product code KWA·May 19, 2011

    Model NuCARTGN. The NuCART is a mobile display and image management platform used in Minimally Invasive Surgery (MIS) environments to facilitate the routing and ergonomic display of video signals from source devices to flat-panel monitors. It is tailored for use with an OEC C-arm and Endo-Cam in MIS surgery suites, Ambulatory Surgery Centers, Urology, GI and other suites.

    FDA Enforcement
    Class II ·Terminated·CompView Medical, LLC·January 20, 2016

    Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully automated system for clinical chemistry analysis.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·December 12, 2012

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L231, PROPONENT DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025