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

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    MOSAIQ ONCOLOGY INFORMATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    Unity Total Knee System

    FDA UDI
    CORIN LTD·05055343897850·Tibial Augment 5mm RL-LM size 5

    SBH

    FDA UDI
    SBH Surgical·00850068304011·1/1, Sterilization Container Perforated Lid, Bl...

    VACCESS LT LONG-TERM HEMODIALYSIS CATHETER

    FDA UDI
    Bard Access Systems, Inc.·00801741010774·VACCESS ST, 14.5 FR. 23cm

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A12323080·12mm H x 32mm W x 30mm L x 8 degrees ALIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A123230150·12mm H x 32mm W x 30mm L x 15 degrees ALIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A123230120·12mm H x 32mm W x 30mm L x 12 degrees ALIF

    ECHOPULSE MUSCLE STIMULATOR SYSTEM, MODEL 800

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 11, 2020

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 22, 2024

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code ILS·May 21, 2013

    INTERMATE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·September 26, 2014

    CAPSUREFIX NOVUS MRI

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code NVN·June 14, 2011

    VERCISE GEVIA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·June 10, 2020

    SCR Ø1.5 SELF-DRILL L6 TAN 4U I/CLIP

    FDA Adverse Event
    Malfunction ·SYNTHES SELZACH·Product code HWC·March 6, 2017

    Siemens Artis Q.zen biplane-Interventional Fluoroscopic X-Ray System Model Number: 10848355

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

    Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q zeego- Model No. 10848283 Artis Q.zen floor- Model No. 10848353 Artis Q.zen ceiling- Model No. 10848354 Artis Q.zen biplane- Model No. 10848355

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 2022

    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

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020