BEUDAMED
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    BIO-EYE II ORBITAL IMPLANT

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    TruForm

    FDA UDI
    Rmo, Inc.·00885797099853·MN 2ND BI BD KT N/L UNIV 123

    SCANLAN® Legacy Needle Holders

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159033410·TI Legacy NH FH W/RAT 10" STRML BL

    VITAPORT 3

    FDA 510(k)
    FDA Class 2 ·Neurology

    MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    RETRACTOR

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code GAD·February 28, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·March 1, 2011

    BD LOGIC BLOOD GLUCOSE MONITOR

    FDA Adverse Event
    Malfunction ·NOVA BIOMEDICAL CORP.·Product code NBW·February 27, 2008

    smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    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