BEUDAMED
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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

    Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·March 4, 2026

    Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·April 29, 2026

    Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Product Description: An assembly of devices intended to generate and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure.

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

    Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.

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

    Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.

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

    Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·April 29, 2026

    Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.

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

    Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·February 25, 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 SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog Number: TFL-SLS containing TFL-CSLU Product Description: An electricity powered device assembly which emits a high-power laser beam to vaporize/ablate soft tissue with moderate hemostasis, little charring, and a thin zone of necrosis. Component: No

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·April 8, 2026

    Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.

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

    Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in urological applications.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·March 4, 2026

    Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3006 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the bipolar outputs of compatible generators.

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

    Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·March 4, 2026

    Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applications.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·March 4, 2026

    Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·March 4, 2026

    Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·February 11, 2026

    Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·March 4, 2026