BEUDAMED
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    OPERATING ROOM STAND

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    NA

    FDA UDI
    Richard Wolf GmbH·04055207043585·TEM OBTURATOR Ø 36MM WL 175MM WL 175mm, reusable

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·10842209121820·

    System, Test, Carcinoembryonic Antigen

    FDA Pre-Market Approval
    FDA Class 2 ·CEA-ROCHE(R) EIA

    ZIMMER PATIENT SPECIFIC INSTRUMENTS/ SYSTEM/PLANNER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM

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

    System, Test, Carcinoembryonic Antigen

    FDA Pre-Market Approval
    FDA Class 2 ·CEA-ROCHE(R) EIA

    System, Test, Carcinoembryonic Antigen

    FDA Pre-Market Approval
    FDA Class 2 ·CEA-ROCHE(R) EIA

    System, Test, Carcinoembryonic Antigen

    FDA Pre-Market Approval
    FDA Class 2 ·CEA-ROCHE(R) EIA

    System, Test, Carcinoembryonic Antigen

    FDA Pre-Market Approval
    FDA Class 2 ·CEA-ROCHE(R) EIA

    System, Test, Carcinoembryonic Antigen

    FDA Pre-Market Approval
    FDA Class 2 ·CEA-ROCHE(R) EIA

    System, Test, Carcinoembryonic Antigen

    FDA Pre-Market Approval
    FDA Class 2 ·CEA-ROCHE(R) EIA

    COULTER LH 500 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·May 30, 2014

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·November 20, 2012

    ENDOPATH** XCEL* STABILITY SLEEVE FOR BLADELESS TROCAR

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·September 21, 2010

    VITROS Chemistry Products LIPA Slides GEN 48, Coating 3235, REF/Catalog No. 166 8409 (60 slides per cartridge and 5 cartridges per box - 300 slides per box) and REF/Catalog No. 829 7749 (18 slides per cartridge and 5 cartridges per box - 90 slides per box). LIPA Slides are processed by higher volume (or mainframe) VITROS Chemistry Systems typically used in hospital laboratories. Ortho-Clinical Diagnostics, a Johnson & Johnson company. Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626. 510(k) #: K845027 (18 January 1985). Shelf life: Cat. # 166 8409: 12/01/07, Cat. # 829 7749: 12/01/07-1/01/08

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CHI·October 9, 2006