BEUDAMED
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    FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PRINCETON

    FDA UDI
    Princeton Medical Group, Inc.·00810158218345·SUCTION TUBE ROSEN 0.7MMØ LUER-LOCK 4"

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707010555·CALIBRA 1ST MOLAR BANDS n.UL 7

    TALOS®-C

    FDA UDI
    SpineArt SA·07640375236357·STERILE TALOS®-C (HA) PEEK PLANAR IBFD

    TALOS®-C HA

    FDA UDI
    MEDITECH SPINE, LLC·B167521305070·

    T.E.A.R. TECH3 MODEL #44TT03

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    XRES BLOOD COLLECTION RESERVOIR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HANDLE CEV669B DIA 5MM ANG BIPOLAR [MXI/XOM]

    FDA Adverse Event
    Malfunction ·XOMED MICROFRANCE MFG·Product code GEI·September 24, 2013

    HANDLE CEV669B DIA 5MM ANG BIPOLAR [MXI/XOM]

    FDA Adverse Event
    Malfunction ·XOMED MICROFRANCE MFG·Product code GEI·September 13, 2013

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FPA·May 24, 2013

    MINICAP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - GUANGZHOU·Product code KDI·September 30, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011

    COBAS® MPX - 480T

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 26, 2025

    ADULT HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·October 28, 2013

    Pump Refill Kit Catalog Number: 7347R1

    FDA Enforcement
    Class II ·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022

    COBAS® MPX - 480T

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 24, 2025

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·October 3, 2013

    DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dural defects and as an adhesion barrier for the reduction of peridural fibrosis. DuraGen Plus matrix is an easy to handle, soft, white pliable, non-friable, porous, collagen matrix. DuraGen Plus matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corporation·May 22, 2013

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) 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

    The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

    FDA Enforcement
    Class II ·Ongoing·Abbott Medical·January 1, 2025