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

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    SUTURE NONABSORBABLE - SILK

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

    Intuitive Workflow Tools

    FDA UDI
    Barco NV·05415334002050·accessories for image enhancement in diagnostic...

    PRECISET DAT AMPHETAMINE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PASSPORT ROBOTIC REDUCER CAP; PASSPORT STOPCOCK WITH ROTATING MALE LUER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    HU-FRIEDY PERMA SHARP SUTURES

    FDA Adverse Event
    Other ·SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH)·Product code GAR·May 26, 2010

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 28, 2013

    WELLFLEX BILIARY RX STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code FGE·December 16, 2010

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·July 12, 2014

    EndoVive 3s Low Profile Balloon Kits Part Number: M00548530 (XMD P/N 70-0050-416) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

    FDA Enforcement
    Class II ·Terminated·Xeridiem Mediem Medical Devices Inc·March 2, 2016

    Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms Reference Part Number (RPN): ZIMB-22-108 ZIMB-22-118 ZIMB-22-128 ZIMB-22-70 ZIMB-22-84 ZIMB-22-98 ZIMB-24-108 ZIMB-24-118 ZIMB-24-128 ZIMB-24-70 ZIMB-24-84 ZIMB-24-98 ZIMB-26-108 ZIMB-26-118 ZIMB-26-128 ZIMB-26-70 ZIMB-26-84 ZIMB-26-98 ZIMB-28-108 ZIMB-28-118 ZIMB-28-128 ZIMB-28-70 ZIMB-28-84 ZIMB-28-98 ZIMB-30-108 ZIMB-30-118 ZIMB-30-128 ZIMB-30-70 ZIMB-30-84 ZIMB-30-98 ZIMB-32-108 ZIMB-32-108 ZIMB-32-118 ZIMB-32-128 ZIMB-32-70 ZIMB-32-84 ZIMB-32-98 ZIMB-36-108 ZIMB-36-118 ZIMB-36-128 ZIMB-36-84 ZIMB-36-98

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·September 23, 2020