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

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

    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.

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

    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.

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

    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.

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

    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.

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

    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.

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

    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.

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

    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.

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

    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111

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

    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330.

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

    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112

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

    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE.

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

    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.

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

    Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures.

    FDA Enforcement
    Class II ·Terminated·Integra Burlington MA, Inc.·April 10, 2013

    The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range.

    FDA Enforcement
    Class II ·Ongoing·IN MY BATHROOM LLC·October 12, 2022

    Carina Ventilator, ventilator. Catalog no. 5704110. Long-term ventilator for treatment in hospitals by a qualified medical personnel.

    FDA Enforcement
    Class II ·Terminated·Draeger Medical, Inc.·June 6, 2018

    Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider

    FDA Enforcement
    Class II ·Ongoing·Turbett Surgical, Inc.·February 8, 2023

    Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider

    FDA Enforcement
    Class II ·Ongoing·Turbett Surgical, Inc.·February 8, 2023

    Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 circuit board, an OEM part manufactured by a third party supplier; and an integral component of the Nellcor SpO2 device. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·May 14, 2014

    Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·February 18, 2015

    Advanced Orthogonal Percussion Adjusting Instrument Indicated for use by a licensed Chiropractor to assist in making Chiropractic adjustments to the Atlas vertebra.

    FDA Enforcement
    Class II ·Terminated·Advanced Orthogonal Equipment, Incorporated·July 31, 2013