BEUDAMED
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    DEN-MAT PAINT-ON RUBBER DAM

    FDA 510(k)
    FDA Class 1 ·Dental

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111224133·GUYON SOUND W/THREAD 30FR

    PHOENIX ANKLE NAIL CONNECTING BOLT

    FDA Adverse Event
    Injury ·BIOMET TRAUMA·Product code LXH·April 10, 2017

    VERIFY STEAM Integrating Indicator

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ROTATOR CUFF QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2014

    VITALITY

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 4, 2010

    SWARTZ BRAIDED TRANSSEPTAL GUIDING IINT, 8F, SLO

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL INC. (AF-MINNETONKA)·Product code DYB·November 27, 2012

    Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 30, 2014