BEUDAMED
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    PULSIOFLEX

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VECTORVISION TRAUMA

    FDA 510(k)
    FDA Class 2 ·Neurology

    ICON (TM) MODULAR PEDICLE SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MRU·December 22, 2015

    OSCOR ADELANTE BREEZWAY 10F STRAIGHT S79CM D84CM Catalog # AB101219 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

    FDA Enforcement
    Class II ·Terminated·Oscor, Inc.·December 28, 2016

    ACCU-CHEK ® COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·May 14, 2013

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    FDA Adverse Event
    GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·March 28, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 15, 2008

    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 L131, ESSENTIO DR EL MRI Pacemaker

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