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

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    HARDYDISK, TETRACYCLINE 30MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    TruFlex

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730013606·NiTi RCS Type 5 Upper 16x22 10 archwires per pack

    TruFlex™

    FDA UDI
    Ortho Organizers, Inc.·00190707125486·TRUFLEX NiTi RCS Type 5 Upper 16x22 (10pk)

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694037464·PrimaLOK SP 4mm Implant Sizer

    PediFlex

    FDA UDI
    ORTHOPEDIATRICS CORP.·00841132133330·INSERT ASSEMBLY

    Valeo Spacer System

    FDA UDI
    SINTX Technologies, Inc.·M555316000304·Tray 2, Phantom Plus PLIF, TLIF System Case 1

    GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04

    FDA 510(k)
    FDA Unclassified ·Unknown

    FlowLogic Agile

    FDA UDI
    SONENDO, INC.·00810209420970·FlowLogic Agile Shaping File 12 Variable, 21mm

    ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OIS-STAND ALONE DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    LUMIRADX SARS-COV-2 AG TEST STRIP KIT

    FDA Adverse Event
    Malfunction ·LUMIRADX UK LTD.·Product code QKP·June 7, 2021

    V 3.0 FIRM EXT

    FDA Adverse Event
    Injury ·CONCENTRIC MEDICAL·Product code NRY·March 12, 2013

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·February 17, 2011

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FRN·February 14, 2008

    ARCTIC FRONT ADVANCE PRO¿ CARDIAC CRYOABLATION CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC CRYOCATH LP·Product code OAE·July 7, 2023

    ACHIEVE ADVANCE MAPPING CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DRF·July 7, 2023

    INSORB 30 STAPLER

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code GAG·August 18, 2022

    Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes

    FDA Recall
    Terminated ·Liberty Medical Supplies·Product code FMF·February 24, 2003

    BrightView XCT

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 22, 2017

    BrightView XCT , Model Number 882482

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·July 31, 2019