BEUDAMED
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    PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    Z Liquid HT D2-S 100ml

    FDA UDI
    ARGEN CORPORATION, THE·D818122155·Dental porcelain/ceramic restoration kit

    SCOTT'S SELECT K-FILES 6/pk 21mm # 55

    FDA UDI
    SCOTT'S DENTAL SUPPLY L.L.C.·D77811221551·ENDODONTIC K-FILES (6/pack) Length: 21mm, Size:...

    ZEUS-L

    FDA UDI
    SPINAL ELEMENTS·00840916120306·Hyper ZEUS®-L 12 x 21 x 55mm, 14 Degree

    ZEUS-L

    FDA UDI
    SPINAL ELEMENTS·00840916134259·Zeus-L, Lateral Lumber Interbody Fusion Device,...

    ZEUS-L

    FDA UDI
    SPINAL ELEMENTS·00840916141004·ZEUS® LLIF 12mm x 21mm x 55mm x 14° TRIAL

    ZEUS-L

    FDA UDI
    SPINAL ELEMENTS·00840916120313·Zeus-L, Lateral Lumber Interbody Fusion Device,...

    ZEUS-L

    FDA UDI
    SPINAL ELEMENTS·00840916140953·ZEUS® LLIF 12mm x 21mm x 55mm x 07° TRIAL

    ZEUS-L

    FDA UDI
    SPINAL ELEMENTS·00840916141042·ZEUS® LLIF 12mm x 21mm x 55mm x 21° TRIAL

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·January 31, 2020

    MR RADIATION ONCOLOGY OPTIONS

    FDA 510(k)
    FDA Class 2 ·Radiology

    ARTHREX KNOTLESS SUTURETAK ANCHOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    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

    UNK TISSUE EXPANDER

    FDA Adverse Event
    Injury ·ALLERGAN·Product code LCJ·May 17, 2013

    VASOVIEW HEMOPRO 2

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·September 18, 2014

    ASR ACETABULAR CUPS 62

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 3, 2011

    SELDRILL-SCHANZSCR Ø5 L200/80 SST

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

    SELDRILL-SCHANZSCR Ø5 L200/80 SST

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

    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