BEUDAMED
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    Reuter Tip Deflecting Wire Guide

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197530231·RZ Tebbet Breast Retractor 180x30...

    M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    UNIVERSAL STRAIGHT SET 2Y MLL

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FPA·November 21, 2007

    32MM MOD HEAD COCR STD NECK

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·May 21, 2018

    TPRLC 133 FP TYPE1 PPS HO 10.0

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·May 21, 2018

    EQUINOXE REVERSE SHOULDER COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code HSD·June 19, 2023

    TALENT

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code MIH·June 20, 2013

    WECK HEMOCLIPS

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code FZP·April 28, 2011

    CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNT·September 23, 2008

    Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·July 31, 2019

    Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·July 31, 2019

    SenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.]

    FDA Enforcement
    Class II ·Terminated·SenTec AG·August 14, 2019

    AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US

    FDA Enforcement
    Class II ·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022