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

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    AIA-PACK BMG

    FDA 510(k)
    FDA Class 2 ·Immunology

    INTELIJET

    FDA UDI
    Smith & Nephew, Inc.·00885554007442·MTO INTELIJET CAP INFLOW WITH VALVE

    VITROS

    FDA UDI
    ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750033201·VITROS 4600 Chemistry System - Refurbished

    Navina™Consumable Set Small

    FDA UDI
    Wellspect AB·07333387025506·Navina Transanal Irrigation. Consumable set sma...

    Navina™Consumable Set Small

    FDA UDI
    Wellspect AB·07392532243868·Navina Transanal Irrigation. Consumable set sma...

    32MM M2A MOD HEAD STD NK

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDL·September 26, 2017

    M2A-TAPER LINER SZ 41/32

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDL·September 26, 2017

    EDENTA

    FDA UDI
    EDENTA ETABLISSEMENT·E312K90044510001·Dowel Pin 15 mm

    Master Series

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746135903·DB BKT MASTER HGW LR 1ST BIC 018 T-12 A+2 R=0

    Apex

    FDA UDI
    ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529587840·Apex Femoral Nail Retrograde Ø 9.0 x 440mm

    HARDYDISK CEFTRIAXONE 30MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    HINGE PEDIATRIC PLATING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PULSE GEN MODEL 102

    FDA Adverse Event
    Malfunction ·CYBERONICS INC·Product code LYJ·June 27, 2014

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·January 7, 2013

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DTQ·October 28, 2010

    Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1) 6802445, (2) 6900440 Software Version: version 3.2 to version 3.8.3 (all available software versions) Product Description: In vitro diagnostic chemistry analyzer.

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc.·July 9, 2025

    VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc.·December 20, 2023

    VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code JJE·January 26, 2024

    VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code JJE·January 26, 2024

    VITROS 4600 Chemistry System, clinical chemistry analyzer

    FDA Enforcement
    Class II ·Terminated·Ortho Clinical Diagnostics·August 14, 2019