BEUDAMED
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    FDA 510(k)
    FDA Class 1 ·Microbiology

    Medtronic Reusable Instruments

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00721902383922·PYRAMESH LARGE OVOID TRAY BASE

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450285947·

    SYRINGE 50ML LL TIP 1ML

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·June 16, 2025

    MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01

    FDA 510(k)
    FDA Class 1 ·Microbiology

    STERILE LATEX POWDERED PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CER BIOLOXD OPTION HD 28MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·August 4, 2023

    ACT ARTIC E1 HIP BRG 28X44MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·August 8, 2023

    COBRA GRASPER INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·April 10, 2013

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·April 1, 2011

    RIATA ST ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 27, 2008

    INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code FOZ·July 8, 2019

    BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.

    FDA Enforcement
    Class II ·Terminated·Becton, Dickinson and Company, BD Biosciences·June 17, 2020

    BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.

    FDA Enforcement
    Class II ·Terminated·Becton, Dickinson and Company, BD Biosciences·June 17, 2020

    BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.

    FDA Recall
    Terminated ·Becton, Dickinson and Company, BD Biosciences·Product code PER·July 8, 2019

    BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.

    FDA Recall
    Terminated ·Becton, Dickinson and Company, BD Biosciences·Product code PER·July 8, 2019

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014