BEUDAMED
    11 results · 8ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part Numbers: CMW-14-190-12G CMW-14-190-18G CMW-14-190-25G CMW-14-190-6G CMW-14-300-12G CMW-14-300-18G CMW-14-300-25G CMW-14-300-6G

    FDA Enforcement
    Class II ·Ongoing·Cook Incorporated·November 20, 2024

    COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Part Number CMW-14-300-12G, Order Number G50791

    FDA Enforcement
    Class II ·Ongoing·Cook Incorporated·April 15, 2026

    COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part Number CMW-14-300-18G, Order Number G50792

    FDA Enforcement
    Class II ·Ongoing·Cook Incorporated·April 15, 2026

    Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMW-14-190-ST HMW-14-300-ST

    FDA Enforcement
    Class II ·Ongoing·Cook Incorporated·November 20, 2024

    Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789

    FDA Enforcement
    Class II ·Ongoing·Cook Incorporated·November 27, 2024

    COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786

    FDA Enforcement
    Class II ·Ongoing·Cook Incorporated·April 15, 2026

    The products involved are DeWALT laser distance measurers, model numbers DW0165, DW0165S, DW0330S and Stanley Fatmax FMHT77506. These products were produced for DeWALT and Stanley by a contract manufacturer.

    FDA Enforcement
    Class II ·Ongoing·STANLEY BLACK & DECKER INC.·January 8, 2020

    Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A

    FDA Enforcement
    Class II ·Ongoing·Skytron, Div. The KMW Group, Inc·July 6, 2022

    Skyton Bracket Flatscreen, Revision 2 & 3-The FS32 is a single monitor mounting bracket intended for use with a 32 inch (maximum) flat screen monitor. Model: FS32

    FDA Enforcement
    Class II ·Ongoing·Skytron, Div. The KMW Group, Inc·June 23, 2021

    Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27" max. screen size Part number 3FCM1

    FDA Enforcement
    Class II ·Ongoing·Skytron, Div. The KMW Group, Inc·April 1, 2020

    Recreo Hair Growth Laser Comb

    FDA Enforcement
    Class II ·Ongoing·OMM Imports, Inc. dba Zero Gravity·March 22, 2023