BEUDAMED
    12 results · 26ms · Sources: EU EUDAMED, US FDA

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    NSI ELT-D DILUTING FLUID 4000ML

    FDA 510(k)
    FDA Class 1 ·Hematology

    PHYSIOLOGICAL ANALYZER CM-710

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ALBUMIN REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ADVANCE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·March 12, 2014

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·November 1, 2012

    GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

    FDA Adverse Event
    Injury ·COOK, INC.·Product code DTK·September 21, 2010

    icumedical ChemoLock Closed Vial Spike w/Skirt, (a) REF CL-80S-4 (4 units) (b) REF CL-80S-5 (5 units). Used in IV administration sets. The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system. The ChemoLock is needlefree and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel.

    FDA Enforcement
    Class I ·Terminated·ICU Medical, Inc.·April 24, 2019

    MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.

    FDA Recall
    Terminated ·Mako Surgical Corporation·Product code OLO·December 22, 2016

    Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code MBI·May 31, 2016

    Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - Pin To Rod Coupling 5/3-4mm Catalog #: 4940-1-020 - Product Usage: Indications Distal radius fractures (intra and extra) articular Intercarpal fracture dislocations Unstable forearm fractures Unstable elbow dislocation Multiple extremity fractures Radial osteotomies Foot and ankle fractures Paediatric fractures

    FDA Recall
    Terminated ·Stryker GmbH Bohnackerweg 1 Selzach Switzerland·Product code JEC·November 21, 2019

    Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in preparation for sterilization of re-usable instruments required for implanting the Triathlon Globalization Implant System for individual patients receiving primary total knee arthroplasty (TKA). Catalog# 6541-9-109

    FDA Recall
    Open, Classified ·Howmedica Osteonics Corp.·Product code FSM·November 24, 2021

    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 20, 2015