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

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    TISSUE CONTAINMENT SYSTEM; 10, 14, 17, 25

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814244·GENUMEDI PT SILVER L VII

    LACTOSORB* 1.5MM SYSTEM TEMPLATE

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036076894·

    Caplugs/Evergreen

    FDA UDI
    CAPlugs·00810044205381·CENT TUBE 15ML UNTHREADED

    Caplugs/Evergreen

    FDA UDI
    CAPlugs·00810044205374·CENT TUBE 15ML UNTHREADED

    Caplugs/Evergreen

    FDA UDI
    CAPlugs·00810044205404·CENT TUBE 15ML UNTHREAD PRNT

    Caplugs/Evergreen

    FDA UDI
    CAPlugs·00810044205398·CENT TUBE 15ML UNTHREADED

    GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BICARB MIXING AND DISTRIBUTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTP·September 24, 2018

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 5, 2025

    FLOGARD

    FDA Adverse Event
    Malfunction ·SHARP CORPORATION OSAKA JAPAN·Product code FRN·October 5, 2014

    PELVICOL ACELLULAR COLLAGEN MATRIX

    FDA Adverse Event
    Injury ·TISSUE SCIENCE LABORATORIES·Product code FTL·April 26, 2013

    3.7MM CANNULATED LOCKING SCREW

    FDA Adverse Event
    Death ·SYNTHES MONUMENT·Product code KTT·June 17, 2011

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Product Code/List Number/Item Code 67PFS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS35; d) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS40; e) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS45; f) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS50; g) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS55

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    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