BEUDAMED
    8 results · 14ms · Sources: EU EUDAMED, US FDA

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    Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920000PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·April 1, 2026

    Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·April 1, 2026

    Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·April 1, 2026

    Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Model/Catalog Number: HACF0533 Product Description: The HALO PKS Cutting Forceps are intended to be passed through a 5 mm laparoscopic cannula. Coagulation is achieved using electrosurgical energy under laparoscopic visualization. The device is intended to be used with the Gyrus ACMI G400 Workstation only.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·April 1, 2026

    DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Large Obturator Trocar (Model Number 330.017) 2. DKS Large Lighted Cannula (Model Number 330.011) 3. DKS Large Kerrison (330.015) 4. DKS Small Obturator Trocar (330.013) 5. DKs Small Lighted Cannula (330.014) 6. DKS Small Kerrison (330.016)

    FDA Enforcement
    Class II ·Ongoing·Folsom Metal Products, Inc.·December 18, 2024

    Small DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Small Obturator Trocar (Model Number 330.013) 2. DKs Small Lighted Cannula (Model Number 330.014) 3. DKS Small Kerrison (330.016)

    FDA Enforcement
    Class II ·Ongoing·Folsom Metal Products, Inc.·December 18, 2024

    BD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog Number: 440981

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Co.·December 11, 2024

    BD EpiCenter Data Management System Version or Model: 440887 Catalog Number: 440887

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Co.·December 11, 2024