BEUDAMED
    295 results · 29ms · Sources: EU EUDAMED, US FDA

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    Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-000, 1107-9603-000, 1107-9604-000, 1107-9610-000, 1107-9612-000, 1107-9616-000, 1107-9617-000, 2066835-001, 2069767-001, 2078800-001, 2091008-001, 2091009-001, M1098876, M1145610, M1220023, M1220854, M1221495, and M1233992

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·January 15, 2025

    Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

    FDA Enforcement
    Class I ·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024

    Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27" max. screen size Part number 3FCM1

    FDA Enforcement
    Class II ·Ongoing·Skytron, Div. The KMW Group, Inc·April 1, 2020

    Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Product Description: Influenza A And Influenza B Multiplex Nucleic Acid Assay; Real Time Nucleic Acid Component: No

    FDA Enforcement
    Class II ·Ongoing·Abbott Diagnostics Scarborough, Inc.·April 23, 2025

    Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Product Description: Influenza A And Influenza B Multiplex Nucleic Acid Assay; Real Time Nucleic Acid Component: No

    FDA Enforcement
    Class II ·Ongoing·Abbott Diagnostics Scarborough, Inc.·April 23, 2025

    Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets Component: No

    FDA Enforcement
    Class II ·Ongoing·Abbott Diagnostics Scarborough, Inc.·April 23, 2025

    Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets Component: No

    FDA Enforcement
    Class II ·Ongoing·Abbott Diagnostics Scarborough, Inc.·April 23, 2025

    Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No

    FDA Enforcement
    Class II ·Ongoing·Abbott Diagnostics Scarborough, Inc.·April 23, 2025

    Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No

    FDA Enforcement
    Class II ·Ongoing·Abbott Diagnostics Scarborough, Inc.·April 23, 2025

    AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev. C., 2. Part # 520-10-000, 3. Part # 520-12-000, 4. Part # 520-14-000, 5. Part # 520-16-000

    FDA Enforcement
    Class II ·Ongoing·Encore Medical, LP·September 1, 2021

    Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)

    FDA Enforcement
    Class I ·Ongoing·EITAN MEDICAL LTD·October 25, 2023

    Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

    FDA Enforcement
    Class I ·Ongoing·Covidien·November 8, 2023

    IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio

    FDA Enforcement
    Class I ·Ongoing·IMPRIS Imaging Inc·November 5, 2025

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024

    McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only

    FDA Enforcement
    Class I ·Ongoing·Covidien·August 28, 2024

    Avance CS2 and Avance CS2 Pro. These anesthesia gas machines are intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

    FDA Enforcement
    Class I ·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024

    Field replacement back up batteries distributed on or after April 1, 2019 for Avance CS2, Avance CS2 Pro, Avance, Amingo, Aespire View anesthesia devices

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare, LLC·July 6, 2022

    VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000

    FDA Enforcement
    Class I ·Ongoing·Ventec Life Systems, Inc.·May 13, 2026

    IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra

    FDA Enforcement
    Class I ·Ongoing·IMPRIS Imaging Inc·November 5, 2025

    100V NEPTUNE 3 ROVER JAPANESE (0703-003-000) 120V NEPTUNE S ROVER (0711-001-000) 230V NEPTUNE 3 ROVER ENGLISH (0703-002-000ENG) 230V NEPTUNE 3 ROVER SPANISH (0703-002-000ES)

    FDA Enforcement
    Class II ·Ongoing·Stryker Corporation·January 15, 2025