BEUDAMED
    48 results · 16ms · Sources: EU EUDAMED, US FDA

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    Product Desc: Product Name: A-OK SATINCRESCENT FULL HANDLE2.3MM ANG Model/Catalog Number: 8065990002 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·August 28, 2024

    Product Desc: Product Name: A-OK SATINSLIT FULL HANDLE2.75MM ANG SG Model/Catalog Number: 8065992761 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·August 28, 2024

    Product Desc: Product Name: A-OK 19G V-LANCE FULL HANDLE1.6MM SATIN Model/Catalog Number: 8065911901 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·August 28, 2024

    Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner Label/Labeling: JADAK JDK-2330 REV B 170512-017

    FDA Enforcement
    Class II ·Terminated·Luminex Corporation·August 28, 2019

    ArrowClarke" PleuraSeal¿ Thoracentesis Kit

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·April 11, 2018

    DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. Product Usage: The DIASTAT¿ anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl- 70, Jo-1, dsDNA, histone and centromere antigens.The test may be used to screen out samples which are negative for all ANAs. Samples that give a positive test result should be further tested to identify the antigen-specific antibody or antibodies present. Quantitative/qualitative ELISA kits are available for the individual detection of Sm, Sm/RNP, Ro (SS-A), La (SS-B), dsDNA and centromere ANAs. Qualitative kits are available for the individual detection of Scl-70 and Jo-1. ANA detection represents one parameter in a multicriterion diagnostic process.

    FDA Enforcement
    Class II ·Terminated·Euro Diagnostica AB·March 14, 2018

    Product Name: TOTALPLUS,25+ 7.5CPM VALV WD6 Model/Catalog Number: 8065751618 Software Version: N/A Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·August 28, 2024

    Product Name: TOTAL PLUS,25+ 7.5CPM VALVE Model/Catalog Number: 8065751617 Software Version: N/A Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·August 28, 2024

    Product Name: 25+ CMB PAK 10K CPM,V,STD 0.9 Model/Catalog Number: 8065752450 Software Version: N/A Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·August 28, 2024

    Product Name: 25+ TOTALPLUSr CP PAK 20K CPM BWV .9 IU Model/Catalog Number: 8065000093 Software Version: N/A Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·August 28, 2024

    DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl-70, Jo-1, dsDNA, histone and centromere antigens.

    FDA Enforcement
    Class III ·Terminated·Euro Diagnostica AB·July 5, 2017

    Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992561 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·August 28, 2024

    Product Name: 25+ CMB PAK 10K CPM,V,WA 0.9 Model/Catalog Number: 8065752451 Software Version: N/A Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·August 28, 2024

    20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·June 5, 2024

    Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.6MM ANG DUAL Model/Catalog Number: 8065992647 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·August 28, 2024

    Product Name: TOTAL PLUS,25+,10K VALVE STD Model/Catalog Number: 8065752437 Software Version: N/A Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·August 28, 2024

    ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·June 5, 2024

    Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.2MM ANGCE Model/Catalog Number: 8065983265 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·August 28, 2024

    Product Name: 25GA VALVED ENTRY SYSTEM,3CT Model/Catalog Number: 8065751658 Software Version: N/A Product Description: Valved Trocar Entry System Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·August 28, 2024

    Product Name: 25+ CMB PAK 7.5CPM,V,STD 0.9 Model/Catalog Number: 8065751767 Software Version: N/A Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·August 28, 2024