BEUDAMED
    13 results · 25ms · 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.
    Filters Regulation: Us FDA ×

    LIGHTSPEED 7.0 CT SCANNER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    Leksell Stereotactic System

    FDA UDI
    Elekta Solutions AB·07340201503157·Leksell MPS Arc w Counter Scale - ARC INNER RIN...

    Myo/Wire II

    FDA UDI
    A & E MEDICAL CORPORATION·10841291101802·SS Suture, 8 per sleeve

    LIGHTLAS 532 PHOTOCOAGULATOR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MODIFICATION TO EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INTRALASE FS2

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HNO·November 21, 2013

    VISX EXCIMER LASER

    FDA Adverse Event
    Injury ·AMO MANUFACTURING USA LLC·Product code LZS·November 5, 2010

    INTRALASE FS2

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HNO·August 20, 2013

    INTRALASE FS2

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HNO·October 30, 2013

    R SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·March 12, 2013

    SCREW

    FDA Adverse Event
    Malfunction ·INTERVENTIONAL SPINE, INC.·Product code MRW·February 15, 2011

    PULSE GEN MODEL 101

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·May 6, 2008

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024