BEUDAMED
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    ML EYE SPEAR, MODEL ML 27 ES

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Procure

    FDA UDI
    Twin Med, LLC·10840330700549·Oxygen Tubing Kink Resistant 25' Green Standard...

    Oxygen Tubing

    FDA UDI
    WESTMED, INC.·00709078014444·Oxygen Tubing Kink Resistant 25' Green Standard...

    GRADIA®

    FDA UDI
    Gc America Inc.·14548161075350·GRADIA® DIRECT Flo - 2 syringes (1.5 g/0.8 mL p...

    GRADIA®

    FDA UDI
    Gc America Inc.·D0470022791·GRADIA® DIRECT Flo - 2 syringes (1.5 g/0.8 mL p...

    DURA-CUF

    FDA UDI
    GE Medical Systems Information Technologies, Inc.·00840682110570·DURA-CUF, THIGH, 1 TB BAYONET, 38 - 50 CM, SINGLE

    GT990402 DIGITAL THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    STAPLETAC2 BONE ANCHOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code PQF·May 23, 2018

    ASR ACETABULAR IMPLANT 58

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·March 13, 2013

    UCHR POST/HOOP SCREW

    FDA Adverse Event
    Malfunction ·INTEGRA RADIONICS, INC.·Product code HAW·January 25, 2011

    ACRYSOF TORIC

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·February 22, 2008

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012

    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