BEUDAMED
    13 results · 29ms · Sources: EU EUDAMED, US FDA

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    EBI ESL PEEK-OPTIMA SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Cure-Thru Clear Cervical Matrices

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·00348783004823·CURE-THRU CMF BOX OF 150 723 CT

    Mini-Sprint®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR70610161·Mini Sprint-Brackets 5-5 Roth .022" 20 Brackets

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193104355·HA PEEK EVOS Curved, , 16mmx11mmx 30mm , FLAT 6...

    Symmetry Surgical

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482051979·Symmetry® Forceps, Tissue, 2x3 Teeth, 6 1/4 in

    GE LOGIQ 700

    FDA 510(k)
    FDA Class 2 ·Radiology

    LSI SOLUTIONS FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES PRODUCT

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    VENTED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·May 26, 2011

    S-ROM M HEAD 36MM +6

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·April 16, 2013

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 18, 2011

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL·Product code HQL·June 13, 2008

    Cobas¿ 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602 module only. Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids. This analyzer is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes and photometric analysis modules

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·May 29, 2013

    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