BEUDAMED
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    Cascadia Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526768451·GENUMEDI PSS GREEN I

    OSS™ Orthopedic Salvage System

    FDA UDI
    Biomet Orthopedics, LLC·00880304239975·

    SMITH & NEPHEW MDF MODULAR SLEEVE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE

    FDA 510(k)
    FDA Class 1 ·Dental

    X-SUIT NIR COVERED BILIARY METALLIC STENT

    FDA Adverse Event
    Malfunction ·MEDINOL LTD.·Product code FGE·December 27, 2017

    OSS RS 14MM LS TIBIAL BEARING

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KRO·August 24, 2023

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 6, 2013

    GIA 60-3.8 SINGLE USE RELOADABLE STAPLER

    FDA Adverse Event
    Injury ·USSC PUERTO RICO·Product code GDW·June 16, 2011

    SINGEL LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET

    FDA Adverse Event
    Injury ·COOK, INC.·Product code DQO·September 5, 2008

    EOS PMP, EOS PMP INTEGRATED

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·May 5, 2021

    DIDECO EOS ECMO M PHISIO

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·May 13, 2021

    SORIN LIFEKIT D905 EOS ECMO

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·October 14, 2021

    EOS PMP, EOS PMP INTEGRATED

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·March 23, 2022

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015

    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017