BEUDAMED
    19 results · 24ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    Arthrex TensionLoc System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Vanguard® Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304271890·

    Vanguard Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304465602·

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A183628150·18mm H x 36mm W x 28mm L x 15 degrees ALIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A18362880·18mm H x 36mm W x 28mm L x 8 degrees ALIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A183628120·18mm H x 36mm W x 28mm L x 12 degrees ALIF

    AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GLUCODR AUTO SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    I-STAT CG8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·May 25, 2023

    BIOMET CC CRUCIATE TRAY 67MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·August 22, 2022

    PALACOS CEMENT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LOD·September 29, 2022

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 4, 2008

    CANCELLOUSSCR SYNAPSE Ø4.5 L28 TAN

    FDA Adverse Event
    Malfunction ·SYNTHES BRANDYWINE·Product code KWP·June 22, 2013

    COULTER LH 750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·July 8, 2011

    BIOMET CC I-BEAM TRAY

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·February 23, 2018

    BIOMET SERIES THIN PATELLA

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·February 23, 2018

    VANGUARD PS OPEN BOX FEMORAL

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·February 23, 2018

    I-STAT CHEM8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JPI·December 17, 2024

    various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·April 26, 2017