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

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    Filters Classification: Class Ii ×

    Reusable distal attachments Models: MH-462, MH-463, MH-464, MH-465, MH-466, MH-483, MH-587, MH-588(US), MH-589, MH-590, MH-591, MH-592, MH-593, MH-594, MH-595, MH-596, MH-597, MH-598, MAJ-289, MAJ-290, MAJ-291, MAJ-292, MAJ-293, MAJ-294, MAJ-295, MAJ-296, MAJ-297, MAJ-663, MAJ-664, MAJ-665, MAJ-666

    FDA Enforcement
    Class II ·Ongoing·Aomori Olympus Co., Ltd.·September 13, 2023

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

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

    VPS Rhythm ECG Accessory Pack, REF RHY-100-ECGO Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters that are traditionally considered CVCs that are intended to be placed in the right atrium, or any location other than the lower 1/3 SVC (e.g. chronic hemodialysis catheters placed in the right atrium).

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·July 18, 2018

    VPS TipTracker Stylet Accessory, REF RHY-177-TTSAP Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters that are traditionally considered CVCs that are intended to be placed in the right atrium, or any location other than the lower 1/3 SVC (e.g. chronic hemodialysis catheters placed in the right atrium).

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·July 18, 2018

    VPS Rhythm ECG Accessory Pack with Johans Adapter, REF RHY-100-ECGJ Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters that are traditionally considered CVCs that are intended to be placed in the right atrium, or any location other than the lower 1/3 SVC (e.g. chronic hemodialysis catheters placed in the right atrium).

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·July 18, 2018

    Peripherally Inserted Midline Catheter Kit with Placement Wire, REF MK-02031-TW Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters that are traditionally considered CVCs that are intended to be placed in the right atrium, or any location other than the lower 1/3 SVC (e.g. chronic hemodialysis catheters placed in the right atrium).

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·July 18, 2018

    Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for prevent contamination of the rinse water. The MAJ-2318 water filter is compatible with OER-ELITE and OER-MINI.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·February 14, 2024

    MAJ-247 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-247 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.

    FDA Enforcement
    Class II ·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021

    MAJ-244 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-244 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.

    FDA Enforcement
    Class II ·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021

    Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent reflux of body fluids.

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

    Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent leakage of body fluids.

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

    Essentia MAJ Laparotomy Std Pack, ESLT53B; Medical convenience kit

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·October 2, 2024

    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-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-2119.

    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

    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