BEUDAMED
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    Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Bernafon

    FDA UDI
    Bernafon AG·05711584055366·SA5 CIC, BE SAPHIRA 5

    ProLift

    FDA UDI
    Life Spine, Inc.·00190837138004·

    ProLift

    FDA UDI
    Life Spine, Inc.·00190837086220·

    MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDICINELODGE ZIPKNOT

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

    VERSYS FEMORAL STEM

    FDA Adverse Event
    Injury ·ZIMMER INC·Product code LPH·February 25, 2016

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 8, 2014

    ASR UNI FEMORAL IMPL SIZE 49

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·June 7, 2013

    THORATEC VENTRICULAR ASSIST DEVICE SYSTEM (DDC)

    FDA Adverse Event
    Malfunction ·THORATEC CORP.·Product code DSQ·June 21, 2011

    Retractor f/Sciatic Nerve Long; Part number: 03.100.014; UDI: 10886982070630

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·May 16, 2018

    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