BEUDAMED
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    R3 XLPE LINERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    R3 XLPE INSERT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JDI·May 25, 2025

    SCREW SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304213999·

    Gibralt

    FDA UDI
    Choice Spine, LP·00840996169950·GIBRALT,CONNECTOR,H2H,C-CONNECT,38-48

    EXETER X3 RIMFIT ACETABULAR CUP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM U-2000

    FDA 510(k)
    FDA Class 2 ·Radiology

    M2A 38MM MODULAR HEAD +3MM NK

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·May 15, 2013

    EPD 60000 RPM

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWE·September 24, 2014

    VASOVIEW HEMOPRO 2 EVH SYSTEM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·May 17, 2011

    M2A 38MM MOD HD+9MM NK NO SKRT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LZO·November 4, 2020

    M2A 38MMX60MM CUP

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·November 4, 2020

    BI-METRIC/X POR NC 14X150

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·November 4, 2020

    ARCOM 28MM RNGLOC LNR HWALL 25

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·March 6, 2025

    UNKNOWN SCREWDRIVER

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWY·March 7, 2018

    REVERSE HUMERAL BEARING ASSEMBLY

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWS·April 13, 2017

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·December 19, 2016

    MALLORY HEAD STEM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·June 4, 2020

    Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    EMBLEM S-ICD Model A209

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

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