BEUDAMED
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    EMPOWR Stem Extender, 50mm

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Carbon

    FDA UDI
    Keystone Industries·H66842204410·FP3D Light Reddish Pink

    FALLER STYLET

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

    SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KIT

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ENCORE HIP INSTRUMENT

    FDA Adverse Event
    Malfunction ·ENCORE MEDICAL, L.P.·Product code HTW·November 7, 2008

    UNKNOWN SPINAL CORD STIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·August 15, 2011

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 16, 2013

    Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3 changers; and Membrane Changer Insert, REF MC-I, each package contains 5 inserts. All are components of the Sentec Digital Monitoring System (SDMS).

    FDA Enforcement
    Class II ·Ongoing·SenTec AG·September 27, 2023

    Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115

    FDA Enforcement
    Class III ·Ongoing·Randox Laboratories Ltd.·May 15, 2024

    CODMAN Disposable Perforator, 14mm. Cranial perforator.

    FDA Enforcement
    Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025