BEUDAMED
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    Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe). Software Version: N/A Product Description: Hand-held, battery-powered ultrasonic Doppler blood-flow detector with LCD numeric display, used with interchangeable probes to detect vascular blood-flow signals and display heart rate; affected units were packaged with a 2 MHz BT2M20S8C fetal probe and labeled for both vascular and fetal applications.

    FDA Enforcement
    Class II ·Ongoing·Koven Technology, Inc.·April 1, 2026

    Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L (2.2cm Tapered to 7.4cm x 30cm), Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Tapered, Rolled, Extra-Long, Individually Wrapped, Box of 50 Item Number 76339,

    FDA Enforcement
    Class II ·Ongoing·Sheathing Technologies Inc·January 7, 2026

    Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA system.

    FDA Enforcement
    Class II ·Ongoing·Dynex Technologies, Inc.·August 27, 2025

    Lazervida 10W diode laser cutter and engraver with Lazervida shield.

    FDA Enforcement
    Class II ·Ongoing·Flux Technology Inc.·June 11, 2025

    GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot, REF5190-7317. A required kit for the GenetiSure Dx Postnatal assay (K1201A).

    FDA Enforcement
    Class II ·Ongoing·Agilent Technologies, Inc.·April 16, 2025

    Brand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reusable Handle for Single Use Heads (Forceps and Scissors) Model/Catalog Number: DFH-1028 Software Version: N/A Product Description: A MST Single Use Forceps or Scissors System consists of a reusable handle and one of a number of single use interchangeable heads. MST Single Use Forceps and Scissor heads are shipped ready to use sterile in a tray with Tyvek lid within a sterile pouch. MST Duet Reusable Handle for Single Use Forceps & Scissor Heads are supplied in a non-sterile condition and must be sterilized prior to and after every use. The blue sleeve the handle is packaged in is not intended to be sterilized and does not maintain sterility. Component: Yes. The MST Duet¿ Reusable Handle for Single Use Heads is the reusable handle component which connect to either Single Use Forceps or Scissors heads.

    FDA Enforcement
    Class II ·Ongoing·MicroSurgical Technology Inc·December 4, 2024

    Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. Each TrackX¿ Snap has a unique set of 2 or more reflective markers. By having unique configurations of reflective markers, it is possible to identify which TrackX Snap is in the field of view of the camera(s). As such, it is also possible to have multiple TrackX Snaps in the field at once and to have different TrackX Snaps for different surgical instruments. The device is considered to be a sterile accessory.

    FDA Enforcement
    Class III ·Ongoing·Trackx Technology Inc·November 6, 2024

    TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; and TrackX Insight Base Modular Instrument Tracker, 6.5L, Model #605-3TX, Sterile.

    FDA Enforcement
    Class II ·Ongoing·Trackx Technology Inc·February 15, 2023

    Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000

    FDA Enforcement
    Class III ·Terminated·OraSure Technologies, Inc.·April 25, 2018

    Buzzaround XL scooters' Product Usage: mobility

    FDA Enforcement
    Class II ·Terminated·Golden Technologies, Inc.·March 26, 2014

    Code Alert Advanced 4-Way Care Solution, CA520 System, PN 9600-1600, RF Technologies. This product is used to alert caregivers when a patient at risk for falls is leaving a bed or chair.

    FDA Enforcement
    Class II ·Terminated·RF Technologies, Inc.·July 3, 2013

    Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform therapeutic plasma exchange.

    FDA Enforcement
    Class II ·Terminated·Apheresis Technologies, Inc.·August 15, 2012

    WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No. 6201463.

    FDA Enforcement
    Class II ·Terminated·Biolase Technology Inc·August 27, 2014

    Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38

    FDA Enforcement
    Class II ·Terminated·Circulatory Technology Inc·July 6, 2016

    ALung Technologies Hemolung Respiratory Assist System (RAS) with CME BodyGuard 323 Infusion Pump(EUA) - Product Usage: an off-the-shelf infusion pump and administration set to provide a 30 mL/hr continuous saline flush to the integrated blood pump bearing.

    FDA Enforcement
    Class II ·Terminated·Alung Technologies Inc·February 10, 2021

    The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14

    FDA Enforcement
    Class II ·Ongoing·Circulatory Technology Inc.·June 23, 2021

    IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Indicated for palliative treatment of biliary strictures produced by malignant neoplasms

    FDA Enforcement
    Class II ·Terminated·IDEV Technologies, Inc.·June 26, 2013

    Aperio ScanScope System. Aperio ScanScope Models, XT, AT, AT Turbo, CS and CSO. Automated digital slide creation and viewing device. It is intended to create and view electronic image files representative of tissue specimens fixed to glass slides.

    FDA Enforcement
    Class II ·Terminated·Aperio Technologies Inc·June 26, 2013

    McKesson Anesthesia Care Product Usage: The McKesson Anesthesia Care system is a computer based system which collects, processes,and records data both through manual entry and from monitors which themselves are attached to patients, such as in the operating room environment. The system provides clinical decision support by communicating potential Adverse Drug Event alerts proactively during the pre-anesthesia evaluation and at the point-of-care. The system is generally indicated in the anesthetizing environment when the anesthesia provider decides to perform a patient assessment, to generate a paper and/or electronic record of the administration of anesthesia to a patient, and to document care.

    FDA Enforcement
    Class I ·Terminated·MCKESSON TECHNOLOGIES INC.·March 12, 2014

    Mc Kesson Anesthesia-Rx Model Number 8.0.2 & 8.0.1 with RapiDispense Product Usage: Automated anesthesia cart that monitors and controls the dispensing of medications, narcotics and supplies during surgical procedures.

    FDA Enforcement
    Class II ·Terminated·MCKESSON TECHNOLOGIES INC·September 4, 2013