BEUDAMED
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    PRO-PICC

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450210550·

    WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106; 4 250 ML CAT. # 1400107; WIENER LAB. GILICEMIA ENZCA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PASCO MIC AND MIC/ID PANELS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    STEALTHSTATION® I7¿ INTEGRATED NAVIGATION SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·May 3, 2013

    HYLAMER NEUT 54OD X 28ID

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDI·September 16, 2014

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPI ES REAGENT

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code MMI·May 18, 2011

    METASUL LDH, HEAD, 56, CODE V, TAPER 18/20

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·April 27, 2018

    METASUL LDH, HEAD, 56, CODE V, TAPER 18/20

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWY·January 31, 2018

    METASUL LDH, HEAD, 40, CODE F, TAPER 18/20

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·June 13, 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 Enforcement
    Class III ·Terminated·Focus Diagnostics Inc·November 7, 2012

    METASUL LDH, HEAD, 44, CODE J, TAPER 18/20

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KXA·October 24, 2017

    METASUL HEAD 28MM L 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·August 7, 2018

    METASUL HEAD 28MM L 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·August 3, 2018

    METASUL, HEAD, M, 32/0, TAPER 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code LZO·March 12, 2018

    METASUL LDH, HEAD, 44, CODE J, TAPER 18/20

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·February 22, 2018

    ECHO BI-MTRC MICR RP SO 5X73

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·June 6, 2018

    METASUL LDH, HEAD, 44, CODE J, TAPER 18/20

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·June 14, 2018

    METASUL LDH, HEAD, 48, CODE N, TAPER 18/20

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·May 18, 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