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

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    Xpert Carba-R

    FDA 510(k)
    FDA Class 2 ·Microbiology

    OCTARAY Mapping Catheter

    FDA UDI
    Biosense Webster Inc·10846835021141·OCTA,PERSEID,2-2-2-2-2,D-CURVE

    VASHE WOUND CLEANSING SYSTEM

    FDA 510(k)
    FDA Unclassified ·Unknown

    SYMBIQ INFUSION AND ADMINSTRATION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

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    FDA Adverse Event
    Other ·B/BRAUN MEDICAL INC.·Product code DYB·November 6, 2003

    PULSED FIELD ABLATION (PFA) CATHETER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code QZI·November 6, 2024

    SPRINT FIDELIS

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·October 10, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY·Product code HQL·July 13, 2011

    OCTARAY MAPPING CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code MTD·January 19, 2024

    MOZEC¿ NC RX PTCA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·MERIL LIFE SCIENCES PRIVATE LIMITED·Product code LOX·December 13, 2022

    OCTARAY MAPPING CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code MTD·February 15, 2024

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·August 29, 2022

    OCTARAY MAPPING CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code MTD·August 29, 2022

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·January 18, 2024

    OCTARAY MAPPING CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code MTD·October 2, 2024

    AMT 12 inch Right Angle Feeding Set with Y-Port Used with Nasogastric/Nasointestinal (NG/NI) tubes.

    FDA Enforcement
    Class III ·Terminated·Applied Medical Technology Inc·March 1, 2017

    Thayer MiniSpacer Dual Spray MDI Adapter Counter Incrementing Actuator with 15mm O.D./I.D. Connections, Reference no. 1543A. The 15 mm Dual Spray MiniSpacer with Counter Incrementing Actuator is a non-sterile, single-use item, intended to dispense aerosolized medication into a breathing circuit or ancillary circuits. MINISPACER adapters are indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. The 15 mm device is installed and operated by licensed healthcare practitioners in clinical settings. The design of the actuator component of REF 1543A has been enhanced by the addition of a linear gear designed to increment the dose-counter on some pMDI canisters. REF 1543A provides standard dimension connectors (15 mm outer diameter x 15 mm inner diameter) for connection to the ventilator circuit. The device design incorporates a dual spray nozzle that allows a path for the medication to travel through the stem and directs the medication through the dual orifices into the airstream

    FDA Enforcement
    Class II ·Terminated·Thayer Medical Corporation·February 15, 2017

    Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722223, (2) 722224, (3) 722225, (4) 722226

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012