BEUDAMED
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    Safety Lancet

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

    NA

    FDA UDI
    Medos International Sàrl·10886705026272·HD Coupler, C-Mount 20mm

    Artman Instruments

    FDA UDI
    Wise Linkers, LLC·D1272423161·Composite Carver and Burnisher ARTMAN

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707061571·BRACKETS 22 T-10 A+10 CUS L/R

    HD COUPLER, C-MOUNT, 20MM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SàRL·Product code FEM·February 26, 2020

    VANGUARD REPROCESSED PULSE OXIMETER SENSORS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IMPAX Agility

    FDA 510(k)
    FDA Class 2 ·Radiology

    HD COUPLER, C-MOUNT, 20MM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SàRL·Product code FEM·March 14, 2020

    DELTA CER HEAD 12/14 36MM +1.5

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code LZO·September 10, 2011

    CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code KRH·November 20, 2008

    GYNECARE TVT EXACT CONTINENCE SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·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