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

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    LD-Oxi system

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613084875·K-Wire, Double Ended, Trocar Point, Diameter 0....

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613084837·K-Wire, Double Ended, Trocar Point, Diameter 0....

    ID NOW COVID-19

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCABOROUGH·Product code QJR·October 27, 2021

    SPONDY SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    G-SCAN-MODEL 9800020000, E-SCAN MODEL 9800010000 AND E-SCAN XQ-MODELS-9800010011/9800010005,9800010009/9800010004

    FDA 510(k)
    FDA Class 2 ·Radiology

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDS·November 7, 2021

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code KRG·October 10, 2014

    OT VERIO TEST STRIPS

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

    POWER PROCESSOR®

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JQP·July 13, 2011

    Artis zeego, Model Number 10280959

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

    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

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018