BEUDAMED
    16 results · 23ms · Sources: EU EUDAMED, US FDA

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    VIDAS CA 125 II ASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    Hillrom™

    FDA UDI
    Baxter Medical Systems GmbH + Co. KG·00887761975866·Trumpf Medical/Medizin Pad TS7000 U14 G

    Pads

    FDA UDI
    Baxter Medical Systems GmbH + Co. KG·00887761968783·Pad TS7000 U14 G

    Conformis Hip System

    FDA UDI
    Conformis, Inc.·00850268007552·3.5MM HEX U-JOINT DRIVER

    VERDICT -II BAR/BZO

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 7, 2025

    ESPRIT¿

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR INC.·Product code NXW·August 6, 2025

    PSPC MATRIXMANDIBLE DBL ANGLE RECON PLATE SMALL/2.5MM THICK

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code JEY·April 26, 2013

    LIGHTSPEED VCT

    FDA Adverse Event
    Injury ·GE MEDICAL SYSTEMS LLC·Product code JAK·April 22, 2011

    PALINDROME RUBY 28/45 SP VT

    FDA Adverse Event
    Malfunction ·TYCO HEALTHCARE/KENDALL·Product code MPB·July 17, 2008

    RUNTHROUGH NS

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 24, 2018

    ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code PNY·October 6, 2016

    RUNTHROUGH NS

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 30, 2018

    Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS. Part Numbers: 101649-45, 1011649-55, 1011649-65, 1011649-75, 1011650-55, 1011650-65, 1011651-45, 1011651-55. The RX Accunet EPS is indicated for use as a guide wire and embolic protection system.

    FDA Enforcement
    Class II ·Terminated·Abbott Vascular·February 6, 2013

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018