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

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    n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks,

    FDA 510(k)
    FDA Class 2 ·Dental

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017866·K-Wire, Double Ended, Trocar Point, Diameter Si...

    NA

    FDA UDI
    MAKO SURGICAL CORP.·00848486020422·ACETABULAR REAMER ¿ 43mm

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017873·K-Wire, Double Ended, Trocar Point, Diameter 0....

    3M™ Unitek™

    FDA UDI
    3M UNITEK CORPORATION·00652221044839·Unitek(TM) Molar Band General Purpose Narrow Re...

    Denovo general purpose dental molar band

    FDA UDI
    Denovo Dental, Inc.·00810059290556·Denovo general purpose dental molar band - Mand...

    HLS UNI EVOLUTION & U-KNEETEC

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SHARPS CONTAINER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 23, 2025

    RETROFLEX 3/ SAPIEN INTRODUCER SHEATH SET

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYB·June 10, 2013

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code MMI·June 2, 2011

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE LTD·Product code FRN·September 16, 2008

    Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2150, MOL1451, MOL1452, MOL1455

    FDA Enforcement
    Class I ·Terminated·Focus Diagnostics Inc·April 13, 2016

    Simplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2650, MOL1451, MOL1452, MOL1455

    FDA Enforcement
    Class II ·Terminated·Focus Diagnostics Inc·April 13, 2016

    Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2850, MOL1451, MOL1452, MOL1455

    FDA Enforcement
    Class I ·Terminated·Focus Diagnostics Inc·April 13, 2016

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024