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Medical device recalls for June 2014

... Portal. Jun-02-2014        Ortho-Clinical Diagnostics             enGen (TM) Laboratory Automation System - ... the issue is addressed. Jun-14-2014        Roche Diagnostics Operations; Inc.          Roche cobas e 602 module ...

News - MassDevice staff - 07/03/2014 - 09:21 - 0 comments - 0 attachments

Medical device recalls for May 2014

... impact. May-07-2014      Siemens Healthcare Diagnostics; Inc        Siemens Healthcare ADVIA Centaur Folate - ... of patient specimens. May-13-2014      Roche Diagnostics Operations; Inc.          ACCU-CHEK Compact Plus - ...

News - MassDevice staff - 06/03/2014 - 09:45 - 0 comments - 0 attachments

Medtech approvals: FDA releases March 2014 PMAs

... HBeAg Immunoassay and Elecsys® PreciControl HBeAg Roche Diagnostics Indianapolis, IN 46250 Approval for the Elecsys ...

News - MassDevice staff - 05/22/2014 - 09:51 - 0 comments - 0 attachments

Preventing plagiocephaly: A conversation with Invictus Medical's Tom Roberts

... device career that had taken him to Boehringer Manheim, Roche Diagnostics and Kinetic Concepts Inc., Roberts took a leave of absence in 2010 ...

Feature - Brian Johnson - 05/02/2014 - 13:49 - 0 comments - 0 attachments

Medtech regulation: FDA releases March 2014 510(k) decisions

... CARTRIDGE CARBON DIOXIDE (CO2) HITACHI CHEMICAL DIAGNOSTICS, INC.510(k) NO: K140248(TRADITIONAL) ATTN: ERIKA AMMIRATI ... AVAILABLE FROM FDA DEVICE: ELECSYS PRECICONTROL TS ROCHE DIAGNOSTICS 510(k) NO: K140534(TRADITIONAL) ATTN: ...

News - Arezu Sarvestani - 04/11/2014 - 09:11 - 0 comments - 0 attachments

Medtech personnel moves for the week of Mar. 10, 2014

... Madaus is new CEO at Carlyle's Ortho-Clinical Diagnostics February 27, 2014 by Chris Walker The ... , Ortho-Clinical Diagnostics , Premier Inc. , Roche , Stryker Corp. , Varian Medical Systems , Vexim , Voce ...

News - MassDevice staff - 03/26/2014 - 14:52 - 0 comments - 0 attachments

Madaus is new CEO at Carlyle's Ortho-Clinical Diagnostics

... Group, the new private equity owner of Ortho-Clinical Diagnostics, the former Johnson & Johnson blood testing unit, named Martin ... testing unit. Madaus, the former chief executive at Roche (PINK: RHHBY ) and Millipore before it was bought out in 2010 by ...

News - Chris Walker - 02/27/2014 - 16:57 - 0 comments - 0 attachments

Medtech approvals: FDA releases December 2013 PMAs

The U.S. Food & Drug Administration releases a list of pre-market approvals granted in December 2013. Summary of PMA Originals & Supplements Approved   O ...

News - MassDevice staff - 03/19/2014 - 12:15 - 0 comments - 0 attachments

Ex-Millipore CEO Madaus steps down from Covidien board

... Madaus was North America president and CEO for Roche (PINK: RHHBY ) and chairman & CEO of Millipore before it was ... Madaus is new CEO at Carlyle's Ortho-Clinical Diagnostics Covidien taps Quanterix CEO for board | Personnel Moves ...

News - Chris Walker - 02/07/2014 - 14:34 - 0 comments - 0 attachments

Medtech regulation: FDA releases February 2014 510(k) decisions

... FROM FDA DEVICE: QUANTA FLASH CENTROMERE INOVA DIAGNOSTICS, INC.           510(k) NO: K123880(TRADITIONAL) ATTN: ... SIMPLEX VIRUS TYPE 1 IGG ELISA TEST GOLD STANDARD DIAGNOSTICS         510(k) NO: K131334(TRADITIONAL) ATTN: NAPLEON  ... PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY ROCHE DIAGNOSTICS                 510(k) NO: ...

News - MassDevice - 03/11/2014 - 10:33 - 0 comments - 0 attachments

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