BEUDAMED
    6,533 results · 41ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    MODIFICATION TO PENTRA 60 AND PENTRA 60C+

    FDA 510(k)
    FDA Class 2 ·Hematology

    HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5

    FDA 510(k)
    FDA Class 2 ·Hematology

    CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MINOS AUTOMATIC CELL COUNTER

    FDA 510(k)
    FDA Class 2 ·Hematology

    ABX PENTRA DX 120: OPTION SPS EVOLUTION

    FDA 510(k)
    FDA Class 2 ·Hematology

    ABX MICROS CRP 200, OPTION IM

    FDA 510(k)
    FDA Class 2 ·Hematology

    ABX PENTRA 60C+ HEMATOLOGY ANALYZER

    FDA 510(k)
    FDA Class 2 ·Hematology

    ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·ADVIA CENTAUR AHBCM ASSAY

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·ADVIA CENTAUR HBC TOTAL ASSAY

    Prime Screen

    FDA UDI
    WONDFO USA CO., LTD.·00816862023671·5-Panel Card; 5 per box; AMP,BZO,COC,OPI,THC

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·LIAISON Murex Anti-HBc and LIAISON Murex Control Anti-HBc

    STAT-SKREEN-H, 3X Cutoff, 20mL

    Device
    EU IVDD · Eu Ivd General ·Biochemical Diagnostics, Inc·On the market·32 countries

    SERIES X-H, 3X CUTOFF, 6x20mL

    Device
    EU IVDD · Eu Ivd General ·Biochemical Diagnostics, Inc·On the market·32 countries

    SERIES XV-H 3X CUTOFF 6x20mL

    Device
    EU IVDD · Eu Ivd General ·Biochemical Diagnostics, Inc·On the market·32 countries

    SERIES IV-H 3X Cutoff 6x20mL

    Device
    EU IVDD · Eu Ivd General ·Biochemical Diagnostics, Inc·On the market·32 countries

    Empower 2®

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746012747·DB BKT SL EMPOWER PASSIVE LR BICUSPID 022 T-7 A...

    Empower 2®

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746010040·DB BKT SL EMPOWER INTERACT LL BICUSPID 022 T-7 ...