BEUDAMED
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    ARIX Wrist System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486009526·MCK ONLAY INSERT TRIAL (SIZE 5 X 9mm)

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486004118·MCK ONLAY INSERT TRIAL (SIZE 5 X 15mm)

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486009519·MCK ONLAY INSERT TRIAL (SIZE 5 X 8mm)

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486009557·MCK ONLAY INSERT TRIAL (SIZE 5 X 12mm)

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486004125·MCK ONLAY INSERT TRIAL (SIZE 5 X 16mm)

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486004101·MCK ONLAY INSERT TRIAL (SIZE 5 X 14mm)

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486009533·MCK ONLAY INSERT TRIAL (SIZE 5 X 10mm)

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486009540·MCK ONLAY INSERT TRIAL (SIZE 5 X 11mm)

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486009564·MCK ONLAY INSERT TRIAL (SIZE 5 X 13mm)

    VIDAS CMV IGG

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code LFZ·December 16, 2016

    ZYNO Z-800 INFUSION SYSTEM MODEL Z-800

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 2, 2025

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 12, 2011

    ECHELON*FLEX60

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 14, 2013

    SYNERGY

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO·Product code LGW·September 16, 2008

    AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US

    FDA Enforcement
    Class II ·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020

    Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

    FDA Enforcement
    Class I ·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024