BEUDAMED
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    ECG100+, ECG200+

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517730749·CoRoent XL+, 8x18x40mm 15°

    Medline Industries, Inc.

    FDA UDI
    MEDLINE INDUSTRIES, INC.·10888277986985·SHAVE PREP KIT

    NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    FDA Adverse Event
    Injury ·COCHLEAR LTD·Product code MCM·July 26, 2020

    SVIEW

    FDA 510(k)
    FDA Class 2 ·Radiology

    EMBO PLUS EMBOLECTOMY CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CAPSUREEPI

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DTB·October 10, 2014

    OT VERIO IQ METER

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

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 13, 2011

    Siemens Artis zeego--Interventional Fluoroscopic X-Ray System Model Number: 10280959

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 10, 2019

    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

    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

    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