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

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    EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    Cardiovascular Procedure Kit

    FDA UDI
    Terumo Cardiovascular Systems Corporation·00699753534322·

    TALOS®-C

    FDA UDI
    SpineArt SA·07640375236449·STERILE TALOS®-C (HA) PEEK PLANAR IBFD

    TALOS®-C HA

    FDA UDI
    MEDITECH SPINE, LLC·B167521608070·

    Vusion CS Plus

    FDA UDI
    Ortho Development Corporation·00822409025541·16 mm x 8 mm x 7 Degree Lordotic

    MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SCOUTPRO 7F CORONARY SINUS LEAD DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CLEARLINK PACLITAXEL SETS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·February 2, 2024

    CLEARLINK SOLUTION ADMINISTRATION SETS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·April 27, 2022

    CLEARLINK SOLUTION ADMINISTRATION SETS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·April 27, 2022

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·October 7, 2025

    VASOVIEW 7 XS

    FDA Adverse Event
    Injury ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·July 7, 2011

    OT VERIO IQ METER

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

    SIGMA 300 S

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code NVZ·October 10, 2014

    Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus Product Usage: Angiographic x-ray system

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 24, 2013

    LMA MADgic, Atomization Device with 3mL Syringe, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 28, 2016

    Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients. Procedures that can be performed with the AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 6, 2017

    Artis zee Biplane, Model No. 10094141; Artis zee Ceiling, Model No. 10094137; Artis zee Floor, Model No. 10094135; Artis zeego, Model No. 10280959 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·March 25, 2020

    Siemens Artis zee systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 12, 2015