BEUDAMED
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    MIM software; System, Image Processing, Radiological

    FDA Enforcement
    Class II ·Ongoing·MIM Software Inc·March 12, 2025

    The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range.

    FDA Enforcement
    Class II ·Ongoing·IN MY BATHROOM LLC·October 12, 2022

    MIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: a) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16; b) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16-15; c) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16-22; d) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16-30; e) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 18 Fr, Product Code 0250-18; f) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 18 Fr, Product Code 0250-18-22; g) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 18 Fr, Product Code 0250-18-30; h) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 22 Fr, Product Code 0250-22; i) MIC* Gastric-Jejunal Feeding Tube Kit - Surgical Placement - 16 Fr, Product Code 0260-16; j) MIC* Gastric-Jejunal Feeding Tube Kit - Surgical Placement - 18 Fr, Product Code 0260-18; k) MIC* Gastric-Jejunal Feeding Tube Kit - Surgical Placement - 22 Fr, Product Code 0260-22;

    FDA Enforcement
    Class I ·Ongoing·Avanos Medical, Inc.·March 13, 2024

    MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16; b) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16-15; c) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16-22; d) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16-30; e) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 18 Fr, Product Code 8250-18; f) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 18 Fr, Product Code 8250-18-22; g) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 18 Fr, Product Code 8250-18-30; h) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 22 Fr, Product Code 8250-22; i) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Surgical Placement - 16 Fr, Product Code 8260-16; j) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Surgical Placement - 18 Fr, Product Code 8260-18; k) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Surgical Placement - 22 Fr, Product Code 8260-22

    FDA Enforcement
    Class I ·Ongoing·Avanos Medical, Inc.·March 13, 2024

    BD Syringe Set 20 DP MIC TBG 0.2MF CKV Anti-Siphon SmartSite VLV Sensing Disc, REF: 10798696; BD Syringe Set 20 DP MIC TBG CKV Anti-Siphon SmartSite VLV Sensing Disc, REF: 10798703;

    FDA Enforcement
    Class II ·Ongoing·CAREFUSION·September 22, 2021

    MicroScan Neg MIC 3J REF C54814

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·April 15, 2026

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·April 15, 2026

    Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PULL Model/Catalog Number: 7180-24

    FDA Enforcement
    Class II ·Ongoing·Avanos Medical, Inc.·June 17, 2026

    Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PULL Model/Catalog Number: 7180-14

    FDA Enforcement
    Class II ·Ongoing·Avanos Medical, Inc.·June 17, 2026

    Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PULL Model/Catalog Number: 7180-20

    FDA Enforcement
    Class II ·Ongoing·Avanos Medical, Inc.·June 17, 2026

    MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data processing module for clinical use.

    FDA Enforcement
    Class II ·Ongoing·Medical Information Technology, Inc.·September 24, 2025

    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·April 29, 2026

    Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PULL Model/Catalog Number: 8180-24

    FDA Enforcement
    Class II ·Ongoing·Avanos Medical, Inc.·June 17, 2026

    Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PULL Model/Catalog Number: 8180-20

    FDA Enforcement
    Class II ·Ongoing·Avanos Medical, Inc.·June 17, 2026

    Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PULL Model/Catalog Number: 8180-14

    FDA Enforcement
    Class II ·Ongoing·Avanos Medical, Inc.·June 17, 2026

    Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spinal surgery

    FDA Enforcement
    Class II ·Ongoing·Medtronic Sofamor Danek USA Inc·May 17, 2023

    Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PUSH OTW Model/Catalog Number: 8170-20

    FDA Enforcement
    Class II ·Ongoing·Avanos Medical, Inc.·June 17, 2026

    Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PUSH OTW Model/Catalog Number: 8170-24

    FDA Enforcement
    Class II ·Ongoing·Avanos Medical, Inc.·June 17, 2026

    The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, liver, kidney, pancreas, etc. The system may acquire data using Axial, Cine, Helical, Cardiac, and Gated CT scan techniques from patients of all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports components and accessories. This device may include data and image processing to produce images in a variety of transaxial and reformatted planes. Further, the images can be post processed to produce additional imaging planes or analysis results. The system is indicated for head, whole body, cardiac, and vascular X-ray Computed Tomography applications. The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare, LLC·July 14, 2021