BEUDAMED
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    TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOG

    FDA 510(k)
    FDA Class 2 ·Dental

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092133569·Biomet 3i Certain®-compatible 4.1mm 30° Multi-U...

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092104347·Biomet 3i Certain®-compatible 4.1mm 30° Multi-U...

    PET SHIPPING SYSTEM

    FDA UDI
    BIODEX MEDICAL SYSTEMS, INC.·00718175001769·Shipping System, PET, Single Dose

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code PQF·May 31, 2018

    ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·March 13, 2013

    DA VINCI S SURGICAL SYSTEM

    FDA Adverse Event
    Other ·INTUITIVE SURGICAL, INC.·Product code NAY·February 9, 2011

    ELECSYS 2010 RACK

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code DHA·February 19, 2008

    HLM TUBING SET

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTM·July 6, 2016

    DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port for use with breathing circuits

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·May 24, 2023

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024