BEUDAMED
    134 results · 14ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Ongoing ×

    Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL, 10/PK - Sterile water is used in making dilutions of samples/transport media in preparation for microbial testing of the sample. It is also used for diluting sterile reagents and microorganism preparations

    FDA Enforcement
    Class II ·Ongoing·Edge Biologicals Inc·April 30, 2025

    TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, Ear

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

    NanoSight LM10 fitted with LM14 module. A laboratory instrument for determination of particle characteristics (e.g. size).

    FDA Enforcement
    Class II ·Ongoing·MALVERN PANALYTICAL LTD·October 5, 2022

    NanoSight LM10 fitted with LM12 module. A laboratory instrument for determination of particle characteristics (e.g. size).

    FDA Enforcement
    Class II ·Ongoing·MALVERN PANALYTICAL LTD·October 5, 2022

    Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·January 20, 2021

    TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia detection or alarms)

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

    Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·December 25, 2024

    Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·December 25, 2024

    Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·December 25, 2024

    Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23054 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·December 25, 2024

    Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·December 25, 2024

    Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·December 25, 2024

    ErgoStar CM 55, Model/Catalog Number: MP01855, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.

    FDA Enforcement
    Class I ·Ongoing·Draeger, Inc.·December 17, 2025

    ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.

    FDA Enforcement
    Class I ·Ongoing·Draeger, Inc.·December 17, 2025

    ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.

    FDA Enforcement
    Class I ·Ongoing·Draeger, Inc.·December 17, 2025

    ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.

    FDA Enforcement
    Class I ·Ongoing·Draeger, Inc.·December 17, 2025

    KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e.g. drill) to a driver bit that fits into the adapter.

    FDA Enforcement
    Class II ·Ongoing·Pro-Dex Inc·April 26, 2023

    Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of converting analog pregnancy test results into text pregnant or not pregnant for display on consumer devices (e.g., smart phone, iPad)

    FDA Enforcement
    Class II ·Ongoing·Church & Dwight Inc·April 19, 2023

    Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110, cardiac monitor application.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·October 30, 2024

    stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery

    FDA Enforcement
    Class II ·Ongoing·Stryker Corporation·January 29, 2025