BEUDAMED
    17 results · 25ms · Sources: EU EUDAMED, US FDA

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    GENTAFIX® (1, 3, 3MV)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526550155·GENUMEDI PT KNEE SUP SILVER L EW VI

    Artman Instruments

    FDA UDI
    Wise Linkers, LLC·D1272422161·Weider Cheek Retractor Tongue Retractor

    Symmetry Weitlaner

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482045213·Symmetry® Retractor, Weitlaner, Sharp, 3x4 Pron...

    SYRINGE 10ML LL BNS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·March 9, 2020

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019517085822·

    COOL-TIP RF ABLATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Tranberg CLS Thermal Therapy System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    HNM MEDICAL

    FDA UDI
    HNM STAINLESS, LLC.·00842962160817·WEITLANER RETRACTOR, 6 1/2", 3X4 PRONGS, SHARP

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 2, 2025

    VERSATAP SUTURE ANCHOR

    FDA Adverse Event
    Malfunction ·ORTHO-DESIGN·Product code MBI·September 15, 2025

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·November 2, 2023

    ALARIS SYSTEM PUMP MODULE

    FDA Adverse Event
    Injury ·CARDINAL HEALTH ALARIS PRODUCTS·Product code FRN·November 19, 2008

    FOLFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·September 9, 2011

    SAGITT SAW-ATTACHM LONG W/T-HANDLE F/TRS

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWE·July 23, 2013

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05023572001 ¿ 05023599001 cobas e 601 module ¿ 04745922001 ¿ 04745922692 ¿ 05036348001 ¿ 05036348692 ¿ 05860652001 cobas e 602 module ¿ 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 series (e 601) is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyze Series (e602) is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·January 24, 2018