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

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    SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    XLIF Decade Plate

    FDA UDI
    Nuvasive, Inc.·00887517316509·XLIF Decade Plate Screw, Fixation Pin

    3M™ Unitek™

    FDA UDI
    3M UNITEK CORPORATION·00652221036841·Unitek(TM) Bicuspid Band General Purpose Narrow...

    Plateau-C Ti

    FDA UDI
    Life Spine, Inc.·00190837068684·14mmx11mmx13mm Plateau-C Spacer

    GUARDIAN II NC HEMOSTASIS VALVE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY SITE MARKER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    VIDAS HCG

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code JLW·November 26, 2020

    PROFEMUR(R) MODULAR FEMORAL NECK

    FDA Adverse Event
    Injury ·MICROPORT ORTHOPEDICS INC.·Product code LWJ·October 3, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 3, 2013

    ENDEAVOR RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·June 21, 2011

    MICROVASCULAR PLUG

    FDA Adverse Event
    Injury ·REVERSE MEDICAL·Product code KRD·September 8, 2021

    MICROVASCULAR PLUG

    FDA Adverse Event
    Injury ·REVERSE MEDICAL·Product code KRD·September 8, 2021

    ESOPHYX Z

    FDA Adverse Event
    Injury ·ENDOGASTRIC SOLUTIONS, INC.·Product code ODE·June 22, 2017

    VIDAS TSH

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code JLW·November 25, 2020

    VIDAS HCG

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code JHI·August 19, 2021

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018