BEUDAMED
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    ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094

    FDA 510(k)
    FDA Class 1 ·Hematology

    PowerPICC SOLO

    FDA UDI
    Bard Access Systems, Inc.·00801741104879·Catheter Placement Kit

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040099575·Feathered Gutta Percha Pts CC

    Affiniti

    FDA UDI
    TORNIER, INC.·00846832023509·HUMERAL HEAD TRIAL SCREW

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·H65810005271·Feathered Gutta Percha Pts CC

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040140489·Feathered Gutta Percha Pts CC

    DIALY-NATE

    FDA UDI
    UTAH MEDICAL PRODUCTS, INC.·H67140005270·SET W/ LUER LOCKING CONNECTIONS AND HEATING COI...

    INSUFFLATION NEEDLE, MODEL R65-933

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    VANGUARD PFR FEMORAL LT SM

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code KRR·May 17, 2018

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 2, 2025

    LAMITRODE S-8 LEAD KIT, 60CM LENGTH

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·February 1, 2017

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·November 26, 2018

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - MAHWAH·Product code DSP·November 4, 2022

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·March 12, 2013

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·February 1, 2011

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM

    FDA Adverse Event
    Death ·MEDTRONIC CARDIOVASCULAR·Product code MIH·February 21, 2008

    KYPHON KURVE BONE FILLER DEVICE 13GA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO·Product code KIH·July 14, 2020

    BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 12, 2013

    PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013