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

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    NEOCARE 20 MICRON BLOOD FILTER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PowerPICC

    FDA UDI
    Bard Access Systems, Inc.·00801741137723·Catheter Placement Kit

    TruLock

    FDA UDI
    Rmo, Inc.·00885797644893·TRULOCK Light Activated Adhesive Kit (40 Capsule)

    TEWA

    FDA UDI
    asia-med GmbH·04251282513214·TeWa PJ-Type 2050: coated acupuncture needles ...

    TEWA

    FDA UDI
    asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG·04251282506223·TeWa PJ-Type 2050: coated acupuncture needles ...

    PenEvac1®-ST, MaxReveal™ Diamond Crystal Blade®

    FDA UDI
    I.C. MEDICAL, INC.·00817688024354·PenEvac1®-ST, MaxReveal™ Diamond Crystal Blade®...

    PTERYFIT IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·May 22, 2024

    PTERYFIT IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·June 24, 2024

    SJM TAILOR ANNULOPLASTY RING, MODEL TARN

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SINGLE SIZE TENDON SPACER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code PQF·May 22, 2017

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·March 12, 2013

    SHILEY DISPOSABLE CANNULA LOW PRESSURE

    FDA Adverse Event
    Injury ·COVIDIEN / FORMERLY TYCO·Product code JOH·February 16, 2011

    INDURA CATHETER

    FDA Adverse Event
    Malfunction ·RICE CREEK MFG·Product code LKK·February 15, 2008

    PELVIC OSTEOTOME 20MM/304MM

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWM·October 22, 2021

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·March 28, 2011

    LUMIRADX SARS-COV-2 AG TEST STRIP KIT

    FDA Adverse Event
    Malfunction ·LUMIRADX UK LTD.·Product code QKP·January 13, 2022

    LUMIRADX SARS-COV-2 AG TEST STRIP KIT

    FDA Adverse Event
    Malfunction ·LUMIRADX UK LTD.·Product code QKP·January 13, 2022

    Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse Generator (PG). Detailed software applications instructions can be found in the associated product literature for the PG being interrogated.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·October 3, 2018

    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·February 5, 2014