BEUDAMED
    21 results · 15ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The Galaxy SystemTM and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedure.

    FDA Enforcement
    Class II ·Ongoing·Noah Medical Corporation·December 3, 2025

    Galaxy System (GAL-001)

    FDA Enforcement
    Class II ·Ongoing·Noah Medical·December 25, 2024

    Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy System (GAL-001)

    FDA Enforcement
    Class II ·Ongoing·Noah Medical·December 18, 2024

    Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

    FDA Enforcement
    Class II ·Ongoing·Noah Medical·January 1, 2025

    Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)

    FDA Enforcement
    Class II ·Ongoing·Medtronic MiniMed, Inc.·April 8, 2026

    intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog Number: IPBF5009G20; ONCORE Pro DAB Chromogen, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60; IP DAB Chromogen Kit 80 ml, REF: IPK5010G80, containing DAB Buffer, Catalog Number: IPBF5009G20; DAB kit, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60 Folate Receptor alpha IHC Assay Kit, REF: IPI4006KG10, containing DAB Buffer, Catalog Number: IPBF5009G20

    FDA Enforcement
    Class II ·Ongoing·Biocare Medical, LLC·November 13, 2024

    MiniMed 530G Insulin Pump (MMT-551, MMT-751)

    FDA Enforcement
    Class II ·Ongoing·Medtronic MiniMed, Inc.·April 8, 2026

    Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/Catalog Number: OBM00002 OBM DAB (Digital Acquisition Box) Software Version: N/A Product Description: OBM00002 OBM DAB (Digital Acquisition Box) Component: No

    FDA Enforcement
    Class II ·Ongoing·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·June 18, 2025

    Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)

    FDA Enforcement
    Class II ·Ongoing·Medtronic MiniMed, Inc.·April 8, 2026

    Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754)

    FDA Enforcement
    Class II ·Ongoing·Medtronic MiniMed, Inc.·April 8, 2026

    BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid injection/aspiration, infusion, venipuncture to obtain blood collection and insulin injection.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·December 13, 2017

    STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code: SXMD1B100-12].

    FDA Enforcement
    Class II ·Ongoing·Ethicon, Inc.·May 18, 2022

    Brand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number: QS Software Version: N/A Product Description: The DRS Vascular Q-Stop Suture Retention Appliance is a sterile, single-use, lightweight device made of biocompatible materials that can be easily installed within minutes to assist with venous access hemostasis. Component: No

    FDA Enforcement
    Class II ·Ongoing·Drs Vascular, Inc·August 27, 2025

    DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361

    FDA Enforcement
    Class II ·Ongoing·DRG International, Inc.·January 22, 2025

    Total Thyroxine (T4) ELISA; REF EIA-1781

    FDA Enforcement
    Class II ·Ongoing·DRG International, Inc.·December 8, 2021

    C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293

    FDA Enforcement
    Class II ·Terminated·DRG International, Inc.·April 13, 2022

    Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva.

    FDA Enforcement
    Class II ·Terminated·DRG Instruments GmbH·August 22, 2018

    DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic

    FDA Enforcement
    Class II ·Terminated·DRG Instruments GmbH·September 4, 2019

    DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013 Product Usage: The Salivary Testosterone ELISA (SlV-3013) is an enzymatic in vitro Assay for the detection of Testosterone in human Saliva. Testosterone levels are measured in fertility studies in men and women. Fertility problems are not diagnosed on the outcome of Testosterone alone but accompanied by other diagnostic means

    FDA Enforcement
    Class II ·Terminated·DRG Instruments GmbH·August 14, 2019

    Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Model Number: R1053618 and R1076709. These are retrofitted device.

    FDA Enforcement
    Class II ·Ongoing·DRE Medical Group Inc·July 5, 2023