BEUDAMED
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    LifeRay Intraoral Handheld X-ray System

    FDA 510(k)
    FDA Class 2 ·Dental

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517631190·CoRoent Ant TLIF Ti, 14x11x30mm 15°

    LCP

    FDA UDI
    Synthes GmbH·10886982166777·3.5MM LCP® MEDIAL DISTAL HUMERUS PLATE 14 HOLES...

    Pomee

    FDA UDI
    POMEE CORPORATION·G15772413050·Rochester pean forceps 5 1/2" curved

    Sure Comfort

    FDA UDI
    ALLISON MEDICAL, INC.·00786227130552·32G x 1/4" (6mm) Single use disposable pen need...

    J & J INSTRUMENTS

    FDA UDI
    J & J INSTRUMENTS INC·00817524026146·ROCHESTER PEAN 5.5" CVD

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019517070347·

    RICHFUL POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    STRYKER BIOZIP SUTURE ANCHOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·May 22, 2024

    OVER-THE-MATTRESS SENSOR PAD

    FDA Adverse Event
    Malfunction ·J. T. POSEY CO.·Product code KMI·September 2, 2011

    HS III PROXIMAL SEAL SYTEM 3.8MM

    FDA Adverse Event
    MAQUET CARDIOVASCULAR, LLC·Product code DXC·September 4, 2014

    TITANIUM HEXALOBE SET SCREW

    FDA Adverse Event
    Injury ·ALPHATEC SPINE INC·Product code NKB·July 22, 2013

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014