BEUDAMED
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    Bio Fluff System

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

    DJO SURGICAL

    FDA UDI
    Encore Medical, L.P.·00190446922797·SPECIAL, EMPOWR ACETABULAR MEDIAL IMPACTOR

    CODMAN

    FDA UDI
    Cerenovus, Inc.·10886704002468·CODMAN Slimline Temporary Aneurysm Clip No 6 Bl...

    ABSORBENT PAPER POINTS

    FDA UDI
    DiaDent Group International·08806383549523·"An absorbent paper points is an endodontic pap...

    SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    REMSTAR PRO WITH C-FLEX CPAP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Widex

    FDA UDI
    Widex A/S·05706069728279·Widex EVOKE E-FS (Silver Grey S-440 ) Telecoil,...

    MERSILENE TAPE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code KDC·November 20, 2018

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAM·June 6, 2019

    PUMP MMT-512LWWB PRDGM INS BL EN LN

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·October 15, 2008

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    BLAZER® II XP

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - COSTA RICA (HEREDIA)·Product code OAD·July 2, 2013

    11.0MM TI HELICAL BLADE 100MM-STERILE

    FDA Adverse Event
    Injury ·SYNTHES ELMIRA·Product code HSB·January 15, 2015

    E-POLY 40MM +3 MAXROM LNR SZ24

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code OIY·January 20, 2020

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·January 3, 2019

    CONTOUR TRANSTAR STAPLER SET

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 30, 2019

    PROXIMATE*75MM LINEAR CUTTER

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 30, 2019

    PROXIMATE*PPH PROCEDURE SET

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 21, 2019

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

    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