BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    NEOLab Clear Aligners

    FDA 510(k)
    FDA Class 2 ·Dental

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113936·GIANNETTI "BIG SPURT" CANNULA 21GA

    COLLAGEN PERIODONTAL MEMBRANE

    FDA 510(k)
    FDA Class 2 ·Dental

    IMAGETILE

    FDA 510(k)
    FDA Class 2 ·Radiology

    QUANTUM MAVERICK MR BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code LOX·October 15, 2008

    ATTAIN STARFIX

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

    HEARTWARE HVAD

    FDA Adverse Event
    Injury ·HEARTWARE, INC.·Product code DSQ·July 2, 2013

    EMBLEM MRI S-ICD Model A219

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021