BEUDAMED
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    AQUAbase nX

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

    PROGRIP LAPAROSCOPIC SELF-FIXATING MESH

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

    FEMTEX TAMPONS AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS; CONSUMER PACKAGES AND BULK PACKAGES

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    MYSTIC II, BELL CUP

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL INC.·Product code HDB·April 17, 2019

    RIATA ST OPTIM ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008

    MAXI MOVE

    FDA Adverse Event
    Malfunction ·BHM MEDICAL INC.·Product code FSA·June 30, 2011

    COGNIS

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 12, 2013

    ACCU-CHEK ® ULTRAFLEX INFUSION SET

    FDA Adverse Event
    Injury ·ROCHE HEALTH SOLUTIONS INC·Product code FPA·August 20, 2013

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026