BEUDAMED
    14 results · 27ms · Sources: EU EUDAMED, US FDA

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    JAWS Nitinol Staple System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ISOLA

    FDA UDI
    DEPUY SPINE, LLC·10705034005096·ISOLA SPINE SYSTEM MCC PLATE 30-50mm

    K-Systems

    FDA UDI
    Coopersurgical, Inc.·00888937025064·T45 Warming Plate

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·March 16, 2021

    Vitalograph Model 2120 In2itive eDiary

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    RSP MODULAR GLENOID BASEPLATE, GLENOID TAPER ADAPTER, RETAINING SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RESTORE ADVANCED RECHARGEABLE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·August 12, 2011

    INTERSTIM

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·November 13, 2008

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 16, 2013

    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 Recall
    Open, Classified ·CooperSurgical, Inc.·Product code PUB·November 15, 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

    CODMAN Disposable Perforator, 14mm. Cranial perforator.

    FDA Enforcement
    Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. The generator is an implantable, multi-programmable pulse generator that delivers electrical signals to the vagus nerve through the lead. The generator is housed in a hermetically sealed titanium case and is powered by a single battery. Electrical signals are transmitted from the generator to the vagus nerve by the lead. The lead and the generator make up the implantable portion of the VNS Therapy System. The VNS Therapy Programming System includes a computer pre-installed with VNS Therapy programming software and a programming wand. The physician uses the programming system to read and change generator settings. The Model 1000 Generator was commercially approved for distribution in the U.S. on October 3, 2017 via PMA P970003/S210. Component: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS).

    FDA Enforcement
    Class II ·Ongoing·LivaNova USA, Inc.·February 5, 2025