BEUDAMED
    20 results · 23ms · Sources: EU EUDAMED, US FDA

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    CASSI II Rotational Core Biopsy System

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

    Ceramco® II Silver™

    FDA UDI
    Dentsply International Inc.·D0011612340·

    VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY

    FDA 510(k)
    FDA Class 1 ·Microbiology

    GLUCOPLUS BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 8, 2024

    OT VERIO IQ METER

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

    PICC, NEONATAL L-CATH 1-LUMEN 24GA X 30CM

    FDA Adverse Event
    Malfunction ·ARGON MEDICAL·Product code LJS·July 3, 2011

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 17, 2008

    UNIVERSA FIRM URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·June 25, 2019

    UNIVERSA FIRM URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·June 25, 2019

    UNIVERSA FIRM URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·June 26, 2019

    UNIVERSA FIRM URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·December 31, 2019

    UNIVERSA FIRM URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·December 31, 2019

    UNIVERSA FIRM URETERAL STENT SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FAD·June 14, 2019

    UNIVERSA FIRM URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·June 26, 2019

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·July 23, 2019

    UNIVERSA FIRM URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·August 27, 2019

    Jackson-Pratt Silicone Flat Drain, 7mm, Full Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·May 31, 2017

    Artis zeego, Model Number 10280959

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    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