BEUDAMED
    356 results · 8ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class I × Status: Ongoing × Clear all

    Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).

    FDA Enforcement
    Class I ·Ongoing·Abbott·July 19, 2023

    CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.

    FDA Enforcement
    Class I ·Ongoing·Maquet Medical Systems USA·December 13, 2023

    Impella LD intravascular micro axial blood pump, Product Number 005082

    FDA Enforcement
    Class I ·Ongoing·Abiomed, Inc.·July 26, 2023

    Impella 2.5 intravascular micro axial blood pump, Product Number 005042

    FDA Enforcement
    Class I ·Ongoing·Abiomed, Inc.·July 26, 2023

    Impella 5.0 intravascular micro axial blood pump, Product Number 005062

    FDA Enforcement
    Class I ·Ongoing·Abiomed, Inc.·July 26, 2023

    Impella CP intravascular micro axial blood pump, Product Number 0048-0032

    FDA Enforcement
    Class I ·Ongoing·Abiomed, Inc.·July 26, 2023

    Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Numbers 0550-0008 and 1000100

    FDA Enforcement
    Class I ·Ongoing·Abiomed, Inc.·July 26, 2023

    Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-0024, 0048-0045, 1000080

    FDA Enforcement
    Class I ·Ongoing·Abiomed, Inc.·July 26, 2023

    FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.

    FDA Enforcement
    Class I ·Ongoing·Abbott Diabetes Care, Inc.·January 21, 2026

    Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e. For use during anesthesia.

    FDA Enforcement
    Class I ·Ongoing·Getinge Usa Sales Inc·February 19, 2025

    FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.

    FDA Enforcement
    Class I ·Ongoing·Abbott Diabetes Care, Inc.·January 21, 2026

    FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.

    FDA Enforcement
    Class I ·Ongoing·Abbott Diabetes Care, Inc.·January 21, 2026

    FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.

    FDA Enforcement
    Class I ·Ongoing·Abbott Diabetes Care, Inc.·January 21, 2026

    Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended to provide positive pressure ventilatory support to adults and pediatrics and optionally infants and neonates.

    FDA Enforcement
    Class I ·Ongoing·Hamilton Medical AG·August 27, 2025

    Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product Description: Common Name: Diagnostic intravascular catheter Description: The Novasight Hybrid catheter is a 3Fr single use, sterile device, which will be able to perform transluminal ultrasound and optical coherence tomography imaging of adults. The catheter is capable of real-time 2D side viewing ultrasound and optical imaging acquired simultaneously providing precisely co-registered images with the ability to produce rapidly post processed rendered longitudinal images of the vessel. Packaging: The Novasight Hybrid Catheter is packaged in a packaging system including the protective packaging and the sterile barrier system.

    FDA Enforcement
    Class I ·Ongoing·Conavi Medical Inc.·April 30, 2025

    STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample.

    FDA Enforcement
    Class I ·Ongoing·SD Biosensor, Inc.·March 23, 2022

    AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits designed for the appropriate level provider to evaluate and treat patients at the point-of-injury / point-of-illness. The original manufacturer labeling, including single use indications, is maintained for each device, which may be used independently and at different times. These specific kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that were recalled as part of RES 98317 with (510(k): K140100).

    FDA Enforcement
    Class I ·Ongoing·North American Rescue LLC.·May 6, 2026

    Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog Number: 7730IALS Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: no

    FDA Enforcement
    Class I ·Ongoing·SunMed Holdings, LLC·February 4, 2026

    Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36-23446 Rev 2 Print Version The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.

    FDA Enforcement
    Class I ·Ongoing·SunMed Holdings, LLC·July 2, 2025

    TruSignal Ear Sensor, REF TS-E-D; Oximeter

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare Finland Oy·July 12, 2023