BEUDAMED
    18 results · 32ms · Sources: EU EUDAMED, US FDA

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    MRCAT brain

    FDA 510(k)
    FDA Class 2 ·Radiology

    ECHO BI-METRIC MICROPLASTY HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304697911·

    S7 / OPMI PROergo

    FDA UDI
    Carl Zeiss Meditec AG·04049539104120·

    PONSKY* NON-BALLOON REPLACEMENT GASTROSTOMY TUBE

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

    NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5')

    FDA 510(k)
    FDA Class 2 ·General Hospital

    IN TOUCH ZX

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL QUEBEC LP·Product code FNL·October 6, 2008

    6800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 22, 2011

    ENDOPATH** ETS45

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 27, 2013

    OMNIFIX®

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FMF·March 6, 2026

    UNKNOWN CERAMIC HEAD

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·June 15, 2023

    Quanta System Sterile Optical Laser Fiber, reusable

    FDA Enforcement
    Class II ·Terminated·Quanta System, S.p.A.·June 16, 2021

    UNKNOWN ZB ACETABULAR LINER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PBI·May 12, 2023

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·June 23, 2003

    G7 OSSEOTI 3 HOLE SHELL 50MM D

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·May 12, 2023

    NOVOTWIST 8 MM (30G)

    FDA Adverse Event
    Injury ·NOVO NORDISK A/S, MS HJOERRING·Product code FMI·August 11, 2016

    CER BIOLOXD OPTION HD 36MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·April 25, 2019

    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