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

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    LUER LOCK SKIRT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    862451

    FDA Adverse Event
    Death ·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code DSI·February 20, 2026

    Solana HSV 1+2/VZV Assay

    FDA 510(k)
    FDA Class 2 ·Microbiology

    NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BASTER HEALTHCARE CORPORATION·Product code FRN·January 23, 2014

    2520274-2012-03659

    FDA Adverse Event
    Injury ·SYNTHES·Product code JDI·December 10, 2012

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·June 23, 2015

    11MM/130 DEG TI CANN TROCH IXATION NAIL 400MM/RIGHT-STER

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HSB·May 18, 2015

    11.0MM TI HELICAL BLADE 95MM-STERILE

    FDA Adverse Event
    Malfunction ·SYNTHES ELMIRA·Product code HSB·May 18, 2015

    PERCUTANEOUS CANN CONNECTING SCREW F/TROCH FIXATION NAILS

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code LXH·May 15, 2015

    BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code FZX·May 15, 2015

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020