BEUDAMED
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    PATIENTNET MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Channels

    FDA UDI
    HENRY SCHEIN, INC.·10304040160517·Channels Flex Assorted Pack 21mm .06 Taperx.0...

    Excel™ Impression Material

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310205243·Safco mono reg set purp impression material 4 crt

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·10843717106941·Paper Points, Taper .06, Size #20, 100pcs/box

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450247655·

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 23, 2025

    CARIS MINITOME BIOPSY INSTRUMENT

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

    HARDYDISK, CEFOTAXIME 30MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    PROMUS ELEMENT¿ PLUS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·March 26, 2013

    UNIVERSAL TORQUE LIMITING ATTACHMENT AXSOS AO FIT

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS SELZACH·Product code LXH·February 16, 2011

    JOURNEY

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC., ORTHOPAEDIC DIV·Product code HSH·March 28, 2008

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018