BEUDAMED
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    The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard.

    FDA Enforcement
    Class II ·Ongoing·Insulet Corporation·October 22, 2025

    Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software Version: all Product Description: The Omnipod 5 iOS App software is available to download through the Apple app store. The Omnipod 5 App is the user interface that controls the Omnipod 5 Automated Insulin Delivery System. It is used to activate/deactivate Pods, display alerts/alarms, and send insulin delivery commands for execution to the Pod. Only available in the US.

    FDA Enforcement
    Class II ·Ongoing·Insulet Corporation·July 2, 2025

    C9-3io Transducer Probe

    FDA Enforcement
    Class III ·Ongoing·Philips Ultrasound, Inc·September 3, 2025

    L15-7io Transducer Probe

    FDA Enforcement
    Class III ·Ongoing·Philips Ultrasound, Inc·September 3, 2025

    L15-7IO TRANSDUCER Transducer Probe

    FDA Enforcement
    Class III ·Ongoing·Philips Ultrasound, Inc·September 3, 2025

    THERMI250 Radiofrequency System. Intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions.

    FDA Enforcement
    Class II ·Terminated·Bios S.r.l.·November 8, 2017

    GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S

    FDA Enforcement
    Class II ·Ongoing·Ohio Medical Corporation·June 25, 2025

    Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00

    FDA Enforcement
    Class II ·Ongoing·Murata Vios, Inc.·February 19, 2025

    muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate

    FDA Enforcement
    Class II ·Completed·Murata Vios, Inc.·January 22, 2025

    Vios Monitoring System Bedside Monitor Model BSM2050

    FDA Enforcement
    Class II ·Ongoing·Murata Vios, Inc.·March 12, 2025

    muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate

    FDA Enforcement
    Class II ·Ongoing·Murata Vios, Inc.·February 5, 2025

    LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00

    FDA Enforcement
    Class II ·Ongoing·LINK BIO CORP·July 31, 2024

    ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single. Part number: 8900-4013 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO 11137-2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring.

    FDA Enforcement
    Class II ·Terminated·Bio-Detek, Inc.·October 15, 2014

    Vacuum Regulator, Push-T-Set Intermittent Suction Unit (PTS-ISU) Product Usage: The vacuum regulator is intended to be used in a medical facility as a means to evacuate media (i.e. fluids) from the body.

    FDA Enforcement
    Class II ·Terminated·Ohio Medical Corporation·July 18, 2018

    The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220. It is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The Bio-Rad MONOLISA Anti-HBs EIA is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection in individuals prior to or following HBV vaccination or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection.

    FDA Enforcement
    Class II ·Terminated·Bio-Rad Laboratories·September 26, 2012

    ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900-4052 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO 11137-2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring.

    FDA Enforcement
    Class II ·Terminated·Bio-Detek, Inc.·October 15, 2014

    Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak Defibrillators, models 9, 10C, 11, 12, 15, 20, 500 and are indicated for Defibrillation, Cardioversion, Pacing, and Monitoring Part Number: 2033

    FDA Enforcement
    Class II ·Terminated·Bio-Detek, Inc.·September 10, 2014

    ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO 11137-2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring.

    FDA Enforcement
    Class II ·Terminated·Bio-Detek, Inc.·October 15, 2014

    ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, 1 single Part number: 8900-4055-40 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO 11137-2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring.

    FDA Enforcement
    Class II ·Terminated·Bio-Detek, Inc.·October 15, 2014

    ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900-4052 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring.

    FDA Enforcement
    Class II ·Terminated·Bio-Detek, Inc.·September 24, 2014