BEUDAMED
    14 results · 26ms · Sources: EU EUDAMED, US FDA

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    CH-60 PLUS /ABNORMAL LOW/BLOOD PLATELET

    FDA 510(k)
    FDA Class 2 ·Hematology

    ACUMED

    FDA UDI
    Acumed LLC·10806378095511·Post-Lat Distal Humerus T-Guide L

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111321481·BRINCKERHOFF RECTAL SPEC MED

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450180242·

    MICRO GUIDE CATHETER XP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DYNALINK BILIARY SELF-EXPANDING STENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BD SYRINGE S2

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·April 2, 2019

    HEARTSINE SAMARITAN 300P AND PAD PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·February 12, 2014

    SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 23, 2012

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code MDS·August 17, 2010

    GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·January 19, 2022

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024