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

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    tremoflo C2 Airwave Oscillometry System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FareTec PST

    FDA UDI
    FARETEC, INC.·B54122210240·FareTec PST, Civilian, orange, soft case.

    SIMPLEX/SARAL

    FDA UDI
    PARAMOUNT SURGICALS, INC.·00852647007764·1 LEVEL CERVICAL PLATE 24 MM

    HEMOSIL HIGH ABNORMAL CONTROL ASSAYED

    FDA 510(k)
    FDA Class 2 ·Hematology

    LINEAR POROUS COATED HIP STEM, SIZE 5; REVELATION HIP STEM, SIZE 8; FOUNDATION POROUS PRESS FIT STEM, SIZE 8;

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 13, 2025

    NEUROFORM 2 MICRODELIVERY STENT SYSTEM

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC CORP, NEUROVASCULAR DIVISION·Product code NJE·November 4, 2008

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 23, 2011

    HYDRATOME? RX 49

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code KNS·July 11, 2013

    Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal cannula, and a tapered-tip inner needle

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021

    BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.

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

    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021