BEUDAMED
    11 results · 18ms · Sources: EU EUDAMED, US FDA

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    EZZIE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Crimpable Stop

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746147111·ARCH STOP CRIMPABLE 2MM 020 ROUND 100/PKG

    JAZZ System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TAPERED COMPRESSION PIN

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CENTURION VISION SYSTEM

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·April 22, 2014

    HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE

    FDA Adverse Event
    Injury ·HEART VALVES SANTA ANA·Product code LWR·November 29, 2012

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code MGB·September 29, 2010

    OSS NON-MOD TIB PLATE LONG 67

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·May 22, 2023

    OSS 7CM SEG ELLIPT FEMORAL RT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KRO·May 22, 2023

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021