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

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    Spectre guidewire

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BIO-CLAD ALL POLY CUP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304001626·

    TOTAL ETCH BONDING AGENT

    FDA 510(k)
    FDA Class 2 ·Dental

    N-HYBRIDE-COMPOSITE LC FLOW

    FDA 510(k)
    FDA Class 2 ·Dental

    DOUBLE MOBILITY HC LINER DIAM 52/28

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·January 4, 2017

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FPA·June 11, 2013

    GLUMA DESENSITIZER

    FDA Adverse Event
    Other ·HERAEUS KULZER, GMBH·Product code KLE·June 2, 2011

    ACCU-CHEK TENDER INFUSION SET

    FDA Adverse Event
    Malfunction ·DISETRONIC MEDICAL SYSTEMS·Product code FOZ·September 10, 2008

    If Hip, Sterile Polar Dressing P/N 10680 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them.

    FDA Enforcement
    Class II ·Terminated·Breg Inc·May 10, 2017