BEUDAMED
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    ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY

    FDA 510(k)
    FDA Class 2 ·Radiology

    SafeGuide®

    FDA UDI
    DIVERSATEK HEALTHCARE, INC.·00816734021149·Esophageal Dilator, 48 French

    MaxFuse VBR, 10 (D) x 12 (W) x 57 (H)

    FDA UDI
    Pioneer Surgical Technology, Inc.·00846468055684·10 (D) x 12 (W) x 57 (H)

    OPUS SPEEDSCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VERSYS FEMORAL STEM

    FDA Adverse Event
    Injury ·ZIMMER INC·Product code LPH·February 25, 2016

    Matrixx System

    FDA UDI
    NEXXT SPINE, LLC·00889929034811·Corpectomy, 12Dx14Wx48H 6°

    Matrixx System

    FDA UDI
    NEXXT SPINE, LLC·00889929064825·Corpectomy, 12Dx14Wx48H 0°

    GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/10MM

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code JWH·November 27, 2019

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013

    CONSTELLATION VISION SYSTEM

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·July 29, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·June 7, 2011

    TRANSMITTER MMT-7841ZW GST5G OUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code PQF·February 5, 2026

    Siemens Artis Q biplane---Interventional Fluoroscopic X-Ray System Model Number: 10848282

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

    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