BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    RESTORELLE Y CONTOUR

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

    TheraSphere Administration Accessory Kit (US)

    FDA UDI
    BIOCOMPATIBLES UK LTD·05060116922073·For use with a TheraSphere Administration Set t...

    TheraSphere Administration Accessory Kit

    FDA UDI
    BIOCOMPATIBLES UK LTD·05060116920246·For use with a TheraSphere Administration Set t...

    FLEXITIME FAST & SCAN LIGHT FLOW

    FDA 510(k)
    FDA Class 2 ·Dental

    COAXIA FLOCONTROL CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code BRZ·May 22, 2013

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 27, 2014

    ATTAIN ABILITY

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·June 14, 2011

    Poly stat Flu A & B Test Manufactured for Polymedco 510 Furnace Dock Road Cortlandt Manor, NY 10567 Tel 800-431-2123 914-739-5400 Fax 914-739-5890. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.

    FDA Enforcement
    Class II ·Terminated·Princeton Biomeditech Corp·September 12, 2012

    TheraSphere Administration Set (Part Number K125914-034). TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable Hepatocellular carcinoma(HCC) who can have placement of appropriately positioned hepatic arterial catheters. The device is also indicated for HCC patients with partial or branch portal vein thrombosis/occlusion.

    FDA Recall
    Terminated ·MDS Canada Inc. DBA MDS Nordion 447 March Road Ottawa Canada Ontario·Product code NAW·February 24, 2009

    Poly stat Flu A & B Test Manufactured for Polymedco 510 Furnace Dock Road Cortlandt Manor, NY 10567 Tel 800-431-2123 914-739-5400 Fax 914-739-5890. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.

    FDA Recall
    Terminated ·Princeton Biomeditech Corp·Product code GNX·March 9, 2012

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019