BEUDAMED
    21 results · 27ms · Sources: EU EUDAMED, US FDA

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    REGEN SPRAY APPLICATOR,

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ArgenZ HT+ 98x30 C3

    FDA UDI
    ARGEN CORPORATION, THE·D818122122·Dental porcelain/ceramic restoration kit

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172973097·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172971215·

    VENUE 40

    FDA 510(k)
    FDA Class 2 ·Radiology

    SMITH & NEPHEW MILTI-PURPOSE STERILIZATION TRAY MODEL 72202428

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 30, 2026

    COBAS INTEGRA 800

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·March 6, 2009

    GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 3 L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 22, 2021

    AJUST ADJUSTABLE SINGLE INCISION SLING

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (COVINGTON)·Product code FTL·May 17, 2013

    JAGWIRE?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code EZB·September 26, 2014

    CONCERTO CRT-D DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·June 13, 2011

    PERITX DRAINAGE BAG

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code PNG·April 3, 2026

    I-STAT CG8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·February 26, 2018

    PERITX DRAINAGE BAG KIT

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code PNG·December 18, 2025

    PERITX DRAINAGE BAG

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code PNG·April 11, 2026

    OPTILENE 7/0 (0,5) 75CM 2XDRC10 CV2 RCP

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAW·November 23, 2022

    ONE TOUCH ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·May 23, 2008

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015