BEUDAMED
    10 results · 18ms · Sources: EU EUDAMED, US FDA

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    TUBING FOR CARDIOPULMONARY BYPASS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HM70 EVO Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BZE·December 22, 2009

    HUDSON THERMAGARD NEBULIZER HEATER

    FDA Adverse Event
    Malfunction ·TELEFLEX·Product code BTT·March 24, 2014

    CD HORIZON

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·November 15, 2012

    LEFT KNEE REPLACEMENT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAY·Product code JWH·September 9, 2010

    REMSTAR AUTO A-FLEX

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·October 7, 2022

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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