BEUDAMED
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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environmental contaminants. The Chemolock is needle free and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel.

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·December 18, 2024

    ICU Medical ChemoLock Bag Spike REF: CL-10

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·November 5, 2025

    ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·November 5, 2025

    ICU Medical ChemoLock Closed Vial Spike REF: CL-80

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·November 5, 2025

    ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·November 5, 2025

    ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·November 5, 2025

    ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·November 5, 2025

    ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·November 5, 2025

    ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·November 5, 2025

    ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·November 5, 2025

    ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·November 5, 2025

    ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·November 5, 2025

    ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·November 5, 2025

    ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·November 5, 2025

    ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·November 5, 2025

    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model No. Z9002 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.

    FDA Enforcement
    Class II ·Terminated·Abbott Medical Optics Inc. (AMO)·September 28, 2016

    30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Integrated ChemoLock Drip Chamber, Spiros, Hanger, Drop-In Red Cap, Item No. CL 3011 Clerestories devices intended for the infusion and withdrawal of fluids.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·April 6, 2016

    31" (78 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros, Bag Hanger, REF: 011-CL3011; 40" (102 cm) Appx 4.9 ml, Admin Set w/ChemoLock, 20 Drop In-Line Drip Chamber, Spiros, Bag Hanger, REF: 011-CL3020; ChemoLock Port w/Spiros, Red Cap, REF: CL-35; 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros, Purple Cap, Hanger, REF: CL3951; 40" (102 cm) Appx 7.7 ml, Admin Set w/ChemoLock w/Red Cap, 20 Drop In-Line Drip Chamber, 0.2 Micron Filter, Spiros w/Red Cap, Bag Hanger, REF: CL3962; 31" (79 cm) Appx 3.5 ml, Admin Set w/ChemoLock Bag Spike with Additive Port, 20 Drop In-Line Chamber w/15 Micron Filter, Spiros, Purple Cap, Hanger, REF: CL3999

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·December 30, 2020

    CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050

    FDA Enforcement
    Class II ·Terminated·CTL Medical Corporation·March 27, 2019

    CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050

    FDA Enforcement
    Class II ·Terminated·CTL Medical Corporation·March 27, 2019