BEUDAMED
    11 results · 27ms · Sources: EU EUDAMED, US FDA

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    IQ-UIP

    FDA 510(k)
    FDA Class 2 ·Radiology

    LCP

    FDA UDI
    Synthes GmbH·10886982168450·LCP® VOLAR DISTAL RADIUS PLATE EXTRA-ARTICULAR ...

    Blade Scalpel

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113509·MINIATURE BLADE #67 (BX/5)

    HAUSMANN ENTERPRISES, LLC

    FDA registration
    HAUSMANN ENTERPRISES, LLC·22 products·🇺🇸 United States

    LSO PET/CT HIREZ 64

    FDA 510(k)
    FDA Class 2 ·Radiology

    IntelAir Nasal Airway Support System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·November 11, 2014

    DURATA STS OPTIM ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 10, 2011

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 23, 2013

    PKG, 5MM PEEK MONOPOLAR HANDLE, P/N 0250080617 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024