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

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    Nutricair Enteral Syringe with ENFit

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

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694036658·.101 X 2.5 K-Wire Metatarsal Reamer Guide Pin

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B16721312313000·

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702777673·ELVAREX 2/KNEE HIGH/PROFILE-SLANT-OPEN TOE-ELEP...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694076548·FPS .101 X 2.5" K-WIRE Sterile Qty 2

    IBC FLOPUMP WITH GBS COATING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·June 7, 2021

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·November 15, 2022

    T:SLIM G5 SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OYC·April 6, 2018

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 6, 2014

    MINICAP TRANSFER SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·September 1, 2011

    HI-TORQUE WHISPER MS 0.014" X 190CM GUIDE WIRE

    FDA Adverse Event
    Injury ·ABBOT VASCULAR·Product code DQX·July 11, 2013

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Enforcement
    Class II ·Ongoing·Abbott Point Of Care Inc.·September 24, 2025

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Recall
    Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

    INTELLIS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·October 24, 2018

    epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2, Sodium Potassium , Ionized Calcium, Glucose, Lactate and Hematocrit.

    FDA Enforcement
    Class II ·Terminated·Epocal·August 21, 2013

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022