BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)

    FDA 510(k)
    FDA Class 2 ·Hematology

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017972·K-Wire, Single Ended, Trocar Point, Diameter Si...

    TriplePlay

    FDA UDI
    DYMEDIX DIAGNOSTICS, INC.·00817377021749·FM5 - Embla-N7000 Bedside Unit

    MYOHEALTH CLENCHING INHIBITOR

    FDA 510(k)
    FDA Unclassified ·Unknown

    US ENDOSCOPY DISTAL ATTACHMENT CAP

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

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE INC.·Product code CHL·March 4, 2025

    CONSTELLATION VISION SYSTEM

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·October 29, 2014

    TENDRIL ST

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·September 9, 2011

    2.15MM X 22MM SPIRAL ROUTER

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 2013

    Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS

    FDA Enforcement
    Class I ·Ongoing·ARROW INTERNATIONAL Inc.·June 12, 2024

    BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408.

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