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

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    NEO TITANIUM MESH, CTI-MEM

    FDA 510(k)
    FDA Class 2 ·Dental

    MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EXACTECH NOVATION EMPIRE ACETABULAR AUGMENT WITH INTEGRIP MODEL 186-01-08/11/13, 186-02-08/11/13, 186-03-08/11/13

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    JRNY BCS PAT RESRF RD 35 MM STD

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·August 30, 2017

    JOSTENT GRAFTMASTER

    FDA Adverse Event
    Death ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·April 24, 2009

    2520274-2013-02522

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HWC·May 14, 2013

    COULTER LH 500 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·September 23, 2014

    DUROM US ACETABULAR COMPONENT 60/54 T

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·May 24, 2011

    JOURNEY POLY TIBIAL INSERT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·June 12, 2017

    PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·October 15, 2025

    ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard(R) technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate the use of the ARROWg+ard(R) antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 14, 2017

    Various products which were contract sterilized.

    FDA Enforcement
    Class II ·Ongoing·Anewmed Corporation·November 6, 2019

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021