BEUDAMED
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    CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line

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

    OptoMonitor 3

    FDA UDI
    Opsens Inc·07540184012077·

    NeoFuse HA Enhanced PLIF/TLIF

    FDA UDI
    XENIX MEDICAL LLC·00818345020399·HA CAGE 20L x 12W x 7H

    NeoFuse Ti3D PLIF/TLIF

    FDA UDI
    XENIX MEDICAL LLC·00818345021471·Ti3D CAGE 20L x 12W x 7H

    Ophthlamic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·10841668115159·BARRAQUER SPECULUM Disposable with Finger tabs ...

    10PW - Penn Power & Light

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588012179·10PW - Penn Power & Light

    TALOS®-C HA

    FDA UDI
    MEDITECH SPINE, LLC·B167522012070·

    FLEXION PERMANENT PACING LEAD

    FDA Adverse Event
    Injury ·OSCOR INC.·Product code DTB·March 22, 2016

    NEODENT IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    STARLIGHT

    FDA 510(k)
    FDA Class 2 ·Neurology

    BD PHASEAL¿ L CONNECTOR C90J

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·August 18, 2022

    TRIAGE BNP TEST FOR BECKMAN COULTER

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code NBC·April 25, 2014

    COLLEAGUE TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·July 29, 2011

    TI COLLAR FOR 6MM DUAL-OPENINGIMPLANTS

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code NKB·July 2, 2013

    BD PHASEAL ¿ L CONNECTOR C90J

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·September 12, 2022

    BD PHASEAL¿ L CONNECTOR C90J

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FPA·September 13, 2022

    Microscan Synergies Plus Negative Urine Combo 2 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.

    FDA Enforcement
    Class I ·Terminated·Siemens Healthcare Diagnostics, Inc.·September 18, 2013

    BD GeneOhm MRSA ACP Assay, Catalog #441639, box 200 tests labeled in part***GeneOhm Sciences Canada, Inc. 2555 Boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm MRSA ACP Assay is a qualitative in vitro diagnostic test for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization. Test is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose MRSA infections nor to guide or monitor treatment for MRSA infections. .

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·September 12, 2012

    BD GeneOhm MRSA ACP Assay Catalog #441637, box 48 tests labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm MRSA ACP Assay is a qualitative in vitro diagnostic test for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization. Test is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose MRSA infections nor to guide or monitor treatment for MRSA infections.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·September 12, 2012