BEUDAMED
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    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526189805·LEVAMED ACTIVE ANKLE SUP BLACK R V

    CADENCE PRECISION INJECTOR, MODEL 103-0304

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Mesh

    FDA UDI
    Nuvasive, Inc.·00887517067401·Sterilization Case, Mesh

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040010594·Zirlux 16+ A2 100X20

    Truliant

    FDA UDI
    Exactech, Inc.·10885862653307·Special Universal Baseplate Tibial Trial, Size 5

    PedFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361022138·Ø8.0 X 35mm Gen 1 Reset Cannulated Screw

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0112350·Tap, 7.50mm, Fixed Sleeve

    TRIFIX SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 14, 2007

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code FPA·March 19, 2013

    35CM BIPOLAR LEAD

    FDA Adverse Event
    Injury ·GREATBATCH MEDICAL·Product code DTB·March 7, 2011

    BIOLOX HEAD HIP IMPLANT

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code JDI·April 25, 2019

    UNKNOWN BIOLOX HEAD

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code LZO·February 13, 2018

    CERASUL, HEAD, M/0, TAPER 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code JDI·November 4, 2019

    bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014

    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