BEUDAMED
    138 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    TTDEYE (brand) Radial Pink, B16112110 - Product Usage: Colored contact lenses

    FDA Enforcement
    Class II ·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020

    TTDEYE (brand) Devil Red, B16112201 - Product Usage: Colored contact lenses

    FDA Enforcement
    Class II ·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020

    TTDEYE (brand) Radial Brown, B16112109 - Product Usage: Colored contact lenses

    FDA Enforcement
    Class II ·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020

    TTDEYE (brand) Black Starshine, B16112100 - Product Usage: Colored contact lenses

    FDA Enforcement
    Class II ·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020

    TTDEYE (brand) Diamonds Starlight, B16112203 - Product Usage: Colored contact lenses

    FDA Enforcement
    Class II ·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020

    TTDEYE (brand) Flower Grey, B16112231 - Product Usage: Colored contact lenses

    FDA Enforcement
    Class II ·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020

    TTDEYE (brand) Flower Brown, B16112210 - Product Usage: Colored contact lenses

    FDA Enforcement
    Class II ·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020

    Product 20 consists of all prod oct under poduct code: KTT and same usage: Item no: 47116201900 COMPRESSION SCREW 1/2IN 47116202300 COMPRESSION SCREW 1-1/2IN 47116202200 COMPRESSION SCREW 1-1/4IN 47116202400 COMPRESSION SCREW 1-3/4IN 47116202100 COMPRESSION SCREW 1IN 47116202000 COMPRESSION SCREW 3/4IN Product Usage: Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

    FDA Enforcement
    Class II ·Terminated·Zimmer Manufacturing B.V.·March 23, 2016

    BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: SafeStep Port Access Kit 22G x 0.75in , SafeStep Port Access Kit 22G x 0.75in with Y-Site, SafeStep Port Access Kit 22G x 1 in , SafeStep Port Access Kit 20G x 0.75in , SafeStep Port Access Kit 20G x 0.75in with Y-Site, SafeStep Port Access Kit 20G x 1 in , SafeStep Port Access Kit 20G x 1 in with Y-Site, SafeStep Port Access Kit 19G x 0.75in , SafeStep Port Access Kit 19G x 0.75in with Y-Site, SafeStep Port Access Kit 19G x 1 in , SafeStep Port Access Kit 19G x 1 in with Y-Site, SafeStep Port Access Kit 20G x 1.5in , SafeStep Port Access Kit 20G x 1.5in with Y-Site, MiniLoc Port Access Kit 20G x 1 in, MiniLoc Port Access Kit 20G x 0.75in, MiniLoc Port Access Kit 22G x 1 in, MiniLoc Port Access Kit 22G x 0.75in, MiniLoc Port Access Kit 19G x 1 in with Y-Site, MiniLoc Port Access Kit 20G x 1 in with Y-Site, MiniLoc Port Access Kit 20G x 0.75in with Y-Site, MiniLoc Port Access Kit 22G x 1.5in with Y-Site, MiniLoc Port Access Kit 22G x 0.75in with Y-Site, PowerLoc Max Port Access Kit 19G x 1.0 in with Y-Site, PowerLoc Max Port Access Kit 19G x 0.75in with Y-Site, PowerLoc Max Port Access Kit 20G x 0.75in with Y-Site, PowerLoc Max Port Access Kit 19G x 1.0 in , PowerLoc Max Port Access Kit 20G x 1.0 in , PowerLoc Max Port Access Kit 20G x 0.75in , PowerLoc Max Port Access Kit 22G x 1.0 in , PowerLoc Max Port Access Kit 22G x 0.75in The syringe is used to pre-flush the catheter prior to placement and may also be used to verify patency post-placement.

    FDA Enforcement
    Class II ·Terminated·Bard Access Systems·March 25, 2015

    BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerLoc Port Access Kit 19G x 1 in, PowerLoc Port Access Kit 20G x 1 in, , , PowerLoc Port Access Kit 20G x 1.5in, PowerLoc Port Access Kit 20G x 0.75in, , , PowerLoc Port Access Kit 22G x 1 in, PowerLoc Port Access Kit 22G x 0.75in, , PowerLoc Port Access Kit 19G x 1 in with Y-Site, , , PowerLoc Port Access Kit 19G x 0.75in with Y-Site, PowerLoc Port Access Kit 20G x 1 in with Y-Site, PowerLoc Port Access Kit 20G x 0.75in with Y-Site The syringe is used to pre-flush the catheter prior to placement and may also be used to verify patency post-placement.

    FDA Enforcement
    Class II ·Terminated·Bard Access Systems·March 25, 2015

    Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5,000 per case 25 sleeves of 200 2 in x 2 in / 5.1 cm x 5.1 cm Model Number: ENC100

    FDA Enforcement
    Class II ·Terminated·Steris Corporation·June 1, 2022

    Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination of Plasminogen Activator Inhibitor Type 1 in human plasma. Catalog # 101201. Spectrolyse PAI-1 is intended for the quantitative determination of Plasminogen Activator Inhibitor Type-1 (PAI-1) activity in human plasma. The test is for in vitro diagnostic use.

    FDA Enforcement
    Class II ·Terminated·Sekisui Diagnostics Llc·December 12, 2012

    ActCel advanced bleeding control Topical Hemostatic Dressing 2in X 2in (5cm X 5cm) 4in X 4in Sterile Contents Soluble Regenerated Cellulose For Bleeding Control For external topical and temporary use only Sterility of contents guaranteed unless individual envelope is damaged or opened. Store at room temperature (41F-104F). Do not autoclave.

    FDA Enforcement
    Class II ·Terminated·Coreva Health Science LLC·June 10, 2015

    Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)

    FDA Enforcement
    Class II ·Terminated·QiG Group LLC·March 30, 2016

    Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400

    FDA Enforcement
    Class II ·Terminated·QiG Group LLC·March 30, 2016

    Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2412 ( 2 x 12 channel)

    FDA Enforcement
    Class II ·Terminated·QiG Group LLC·March 30, 2016

    SafetyGlide Needle, 22GA 1-1/2in, Catalog n. 301701, manufactured by BD, sold in Centurion Convenience Kits. Centurion component code BD17O1NS.

    FDA Enforcement
    Class II ·Terminated·Centurion Medical Products Corporation·January 10, 2018

    Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT. White, bleached, non-woven, rayon/polyester sterile Gauze Pad 3 inch x 3 inch, 12-ply 10 count cardboard box

    FDA Enforcement
    Class II ·Ongoing·ASO, LLC·December 12, 2018

    3 in 1 STI Test

    FDA Enforcement
    Class II ·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025

    2 in 1 Trichomonas / Gardnerella Test

    FDA Enforcement
    Class II ·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025