BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    MINI VIBRATOR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    VANTAGE TITAN 3T

    FDA 510(k)
    FDA Class 2 ·Radiology

    CARESIDE ALT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    POLARIS 5.5 STANDARD IMPLANT KIT

    FDA Adverse Event
    Injury ·EBI, LLC.·Product code KWP·January 17, 2013

    ZEPHYR DR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code LWP·July 8, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2015

    The VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems are designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizing vessel branches. The harvesting tool has two curved jaws. One of the jaws contains the heating elements for branch cutting and cauterization and spot cautery. An area near the tip of the convex side of the jaw is used for spot cautery. The activation toggle is used to control the jaws to activate the heating elements. Positioning of the device, cutting, and cauterization are performed under endoscopic visualization.

    FDA Recall
    Open, Classified ·Maquet Cardiovascular, LLC·Product code GEI·May 17, 2024

    The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1. VasoView Hemopro 2, Model Number: VH-4000. 2. VasoView Hemopro 2 with Vasoshield. Model Number: VH-4001. The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting Systems are designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizing vessel branches. The harvesting tool has two curved jaws. One of the jaws contains the heating elements for branch cutting and cauterization and spot cautery. An area near the tip of the convex side of the jaw is used for spot cautery. The activation toggle is used to control the jaws to activate the heating elements. Positioning of the device, cutting, and cauterization are performed under endoscopic visualization.

    FDA Recall
    Open, Classified ·Maquet Cardiovascular, LLC·Product code GEI·May 17, 2024