BEUDAMED
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    GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Extend Frame system

    FDA UDI
    Elekta Instrument AB·07340048306706·CT ADAPTER

    PILLING

    FDA UDI
    TELEFLEX INCORPORATED·24026704506235·

    Ophthalmic Forceps

    FDA UDI
    KATENA PRODUCTS, INC.·00841668111246·COLIBRI FORCEPS 0.12MM TITANIUM

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07310K0115200·Needle, Bevel Stylet, Stainless Steel, Disposable

    Medline

    FDA UDI
    MEDLINE INDUSTRIES, INC.·10884389028001·CLEAR POLY DRAPE, 18 X 30 W/3" FENS

    EPIDURAL CATHETERIZATION SET

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code OGE·January 24, 2019

    ALPHA OMEGA DUAL COOLER-HEATER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RESTORE-X

    FDA 510(k)
    FDA Class 2 ·Dental

    General Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00840180500866·STIRRUP SCRAPER, UP-ANGLED - 18MM

    General Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00840180500859·STIRRUP SCRAPER, UP-ANGLED - 16MM

    General Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00840180500842·STIRRUP SCRAPER, UP-ANGLED - 14MM

    General Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00840180500835·STIRRUP SCRAPER, UP-ANGLED - 12MM

    DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

    FDA Adverse Event
    Injury ·MPRI·Product code NVN·April 10, 2013

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS·Product code LYJ·September 2, 2014

    CAPSUREFIX

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 12, 2011

    EPIDURAL CATHETERIZATION SET

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code CAZ·March 14, 2016

    STEPPED, RATCHET DRILL SLEEVE

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code MDM·September 15, 2016

    Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013