BEUDAMED
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    NON-STERILE POWDER FREE BUBBLE-GUM SCENTED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092130599·Astra®-compatible Aqua 3.5/4.0 mm Straight Mult...

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092102497·Astra®-compatible Aqua 3.5/4.0mm Straight Multi...

    AirLife

    FDA UDI
    Carefusion Corporation·10885403039102·Airlife™ Sidestream® High-Efficiency...

    AirLife™

    FDA UDI
    VYAIRE MEDICAL, INC.·10190752156555·Sidestream™ High-Efficiency Nebulizer

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092002175·artVeneer life lower posteriors, M, BL2

    G21 Flex Beads, 5cc

    FDA UDI
    DIMENSIONAL BIOCERAMICS LLC·00850018568197·CALCIUM SULFATE BONE VOID FILLER

    SERAGARD VASCULAR ACCESS PATCH

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HARDYDISK TICARILLIN 75MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Palladian™

    FDA UDI
    NEUROSTRUCTURES, INC·00841508102892·Non-Cannulated Tap 7.5mm

    HEARTSINE SAMARITAN 300P AND PAD PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·February 11, 2013

    PINNACLE MTL INS NEUT36IDX52OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·February 18, 2011

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORPORATION·Product code MVK·July 3, 2014

    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

    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

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016