BEUDAMED
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    SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AtoN Optic Only

    FDA UDI
    LONG ISLAND TECH·00851610007114·Light, Surgical, Endoscopic, Accessory

    Alpha-Tec Systems

    FDA UDI
    Alpha-TEC Systems, Inc.·00816085020549·Nocardia Stain Control Slides

    GEN4 DIGITAL

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828188890·GEN4 DIGITAL

    GEN4 INTERACTIVE

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828158237·GEN4 INTERACTIVE

    MULTI-PULSE 2000

    FDA 510(k)
    FDA Class 2 ·Dental

    CARTO EP NAVIGATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013

    PINNACLE HIP

    FDA Adverse Event
    Injury ·DEPUY·Product code KWA·February 18, 2011

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·February 21, 2008

    BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·July 14, 2020

    KYPHON KURVE BONE FILLER DEVICE 13GA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO·Product code KIH·July 14, 2020

    VERCISE GENUS?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code MHY·July 18, 2025

    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