BEUDAMED
    19 results · 21ms · Sources: EU EUDAMED, US FDA

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    .DECIMAL PHOTON BLOCK

    FDA 510(k)
    FDA Class 2 ·Radiology

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193100234·EVOS Straight HA PEEK 15mm x 9mm x 26mm Biconve...

    Spine Innovation Interbody System

    FDA UDI
    SPINE INNOVATION, LLC·00817722020380·Expandable Implant 5° x 12mm W x 15mm H x 30mm L

    Apache

    FDA UDI
    Genesys Orthopedics Systems LLC·M719GLLTIS1230150·Small 15 DEG Titanium LLIF

    ODRC-DYNAMIC HIP SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CARDIS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INTERCHANGEABLE ULNAR ASSEMBLY

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDC·October 22, 2019

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 21, 2013

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OZO·September 26, 2014

    PALMAZ-SCHATZ BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·CORDIS CORPORATION·Product code MAF·June 14, 2011

    INTELLIS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·May 31, 2019

    INTERCHANGEABLE HUMERAL ASSEMBLY

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDC·October 22, 2019

    Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848354 Artis Q.zen Floor, Model No. 10848353 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

    Artis Q.zen biplane, Model Number 10848355

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

    ARTIS Q, Interventional Fluroscopic x-ray system

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·March 29, 2017

    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 Q/ Q zen systems; Artis Q/ Q zen systems are 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·April 22, 2015

    Artis Q Interventional Fluoroscopic X-Ray System, Model Numbers 10848280, 10848281, 10848282, 10848283, 10848354 & 10848355

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 26, 2018

    Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355 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. Procedures that can be performed with the Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis can also support the acquisition of position triggered imaging for spatial data synthesis.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 22, 2018