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

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    iTotal® Identity Posterior Stabilized Knee Replacement System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772344116·PROTECT.PRO ACTION BACK SUPPORT BLACK M

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694019323·3mm Periosteal Elevator, Curved Edge

    10M - Southwest Gas Corp

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588010434·10M - Southwest Gas Corp

    FAA Airline - 24 Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588013237·FAA Airline - 24 Metal

    Mui Scientific

    FDA UDI
    H & A Mui Enterprises Inc·10678467003932·Customized Single-Use 20 Ch. Esophageal Pediatr...

    HEMOSIL NORMAL CONTROL (ASSAYED); HEMOSIL NORMAL CONTROL 1 (UNASSAYED)

    FDA 510(k)
    FDA Class 2 ·Hematology

    FREEDOM, MODEL 4660

    FDA 510(k)
    FDA Unclassified ·Unknown

    BD PLASTIPAK¿ - 3-PIECE SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·April 27, 2022

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008

    UNIVERSAL HIGH TORQUE DRILL

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code ERL·July 1, 2011

    RX ERCP CANNULA

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code GCJ·July 2, 2013

    HANDPIECE MICS

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·December 3, 2018

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EGS·November 16, 2020

    ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.

    FDA Enforcement
    Class II ·Terminated·Abbott Gmbh & Co. KG·April 29, 2020

    TOSHIBA Kalare Diagnostic X-Ray System K110785

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·July 17, 2013

    EMBLEM MRI S-ICD Model A219

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.

    FDA Enforcement
    Class III ·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016