BEUDAMED
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    KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (SALI)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    BD PLASTIPAK¿ LUER-LOK¿ SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·February 4, 2020

    BD PLASTIPAK LUER-LOK SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·April 17, 2020

    BD PLASTIPAK LUER-LOK SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·April 17, 2020

    BD PLASTIPAK LUER-LOK SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·April 17, 2020

    FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL MD-534

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NATURAL-KNEE II PATELLOFEMORAL JOINT PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·June 30, 2014

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·January 8, 2013

    PULSE GEN MODEL 102

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·November 11, 2010

    STEALTHSTATION¿ S8 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·August 14, 2025

    50 ML BD PLASTIPAK LUER-LOK SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·May 3, 2019

    DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

    ADVIA Centaur CP System, Catalog/Part Number 086-A001. Automated Immunoassay Analyzer. --- Classification of the Device: Under 21 CFR, Part 862.2160, the ADVIA Centaur CP is a discrete photometric chemistry analyzer for clinical use and is classified as a Class I (general control) device. --- The ADVIA Centaur CP is part of Bayer's Immunochemistry analyzer family, which also includes the ADVIA Centaur and the ACS:180. Based on FDA guidance for deciding when regulatory filings are warranted for device modifications, as well as, the FDA Instrument Family and Replacement Reagent Policy Guidance, Bayer determined that the changes associated with the ADVIA Centaur CP did not affect the safety and effectiveness of the predicate device (ACS:180) and therefore no device modification 510(k) was warranted. The ADVIA Centaur CP instrument uses the same reagents as the ADVIA Centaur. The ACS:180 was cleared by FDA under 510(k) # K902336, and the ADVIA Centaur was cleared by FDA under 510(k) # K971418. The ADVIA Centaur CP system was released for sale in November 2005 and distribution of these systems began at that time. All ADVIA Centaur CP Systems are impacted. There is no expiration date for these systems.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics·Product code JJE·November 9, 2006