BEUDAMED
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    EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT

    FDA 510(k)
    FDA Class 2 ·Dental

    ACE

    FDA UDI
    ACE SURGICAL SUPPLY CO., INC.·00614950026562·LATEX TUBING 3/16"x3/32" BLACK 50' RL NS W/L

    Baltic Denture System BD Load

    FDA UDI
    Merz Dental GmbH·D7091032953·Baltic Denture System BDLoad ↓ Lm6 PLSEum4DFl C...

    Lip Bumper

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746156922·FIXED FUNCT LIP BUMPER 045 96MM BALL CLASP HK D...

    GIOTTO IMAGE

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    BD¿ LARGE SHARP COLLECTOR, RED, LIQUID ABSORBING PAD, 34L

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·May 5, 2022

    NOVA MAX PLUS GLUCOSE MONITOR

    FDA Adverse Event
    Malfunction ·NOVA BIOMEDICAL CORPORATION·Product code NBW·April 1, 2013

    VIRTUOSO DR

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code LWS·March 29, 2011

    C-SERIES

    FDA Adverse Event
    Other ·I-FLOW CORP.·Product code MEB·April 23, 2008

    West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen Wells, Catalog Number EL0351, Lot Number 121117. 510(k) No. K031953 The Focus Diagnostics West Nile Virus ELISA IgG is intended for qualitatively detecting IgG antibodies to West Nile virus in human serum. In conjunction with the Focus Diagnostics West Nile Virus IgM Capture ELISA, the test is indicated for testing persons having symptoms of meningoencephalitis, as an aid in the presumptive laboratory diagnosis of West Nile virus infection.

    FDA Enforcement
    Class III ·Terminated·Focus Diagnostics Inc·November 7, 2012

    West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen Wells, Catalog Number EL0351, Lot Number 121117. 510(k) No. K031953 The Focus Diagnostics West Nile Virus ELISA IgG is intended for qualitatively detecting IgG antibodies to West Nile virus in human serum. In conjunction with the Focus Diagnostics West Nile Virus IgM Capture ELISA, the test is indicated for testing persons having symptoms of meningoencephalitis, as an aid in the presumptive laboratory diagnosis of West Nile virus infection.

    FDA Recall
    Terminated ·Focus Diagnostics Inc·Product code NOP·October 3, 2012

    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

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024