BEUDAMED
    12 results · 45ms · Sources: EU EUDAMED, US FDA

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    Diagramm Halbach GmbH & Co.KG

    Importer
    🇩🇪 Germany·8 Manufacturers

    A.M.I. - Analytical Medical Instruments, s.r.o.

    Importer
    🇨🇿 Czechia·19 Manufacturers

    Obelis s.a.

    Authorized representative
    🇧🇪 Belgium·546 Manufacturers·18515 Devices

    POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA; (2) curaplex, REF 301-0318LT, Medium Concentration, Distributed by Sarnova HC, LLC's family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc., Dublin, OH; and (3) POM Medical, LLC REF 1001-MF, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA. All are packaged 1 mask/plastic pouch, 30 masks/case.

    FDA Enforcement
    Class II ·Terminated·POM Medical LLC·November 6, 2019

    SUNGO Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·1571 Manufacturers·20390 Devices

    Viscocel and Viscocel Plus. These products are intraocular fluid devices consisting of non-gaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical trauma, or function as a tamponade during retinal reattachment.

    FDA Recall
    Terminated ·C.L.R. Medicals International, Inc.·Product code LZP·November 25, 2013

    DuraspanTM Dialysis Catheters, Ultra and Long Term, 15.5 Fr, Sterile EO, Manufactured for r4 Vascular, Inc . 7550 Meridan Circle North, Suite 150, Maple Grove, MN 55369. Description Model # Duraspan Kit - 24cm 62152420 Duraspan Kit - 28cm 62152820 Duraspan Kit - 32cm 62153220 Duraspan Exchange Kit - 32cm 62153228 Duraspan Kit - 36cm 62153620 Duraspan Exchange Kit - 36cm 62153628 Duraspan Kit - 40cm 62154020 Duraspan Exchange Kit - 40cm 62154028 Duraspan Kit - 55cm 62155520 Duraspan Ultra Kit - 24cm 621524E0 Duraspan Ultra Kit - 28cm 621528E0 Duraspan Ultra Kit - 36cm 621536E0 Duraspan Ultra Kit - 40cm 621540E0 Duraspan Ultra Kit - 55cm 621555E0 The r4 DuraspanTM and the DuraspanTM Ultra long-term dialysis catheter are indicated for attaining short and long term (>30 days) vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, external jugular vein, subclavian vein or femoral vein. Catheters 40 cm and longer are for femoral vein insertion. The ability of the Biomimetic Coating to reduce platelet adhesion and thrombus accumulation is supported exclusively by in-vitro and animal testing.

    FDA Recall
    Terminated ·R4 Vascular Inc·Product code MSD·May 3, 2011

    preOx.RS GmbH

    Importer
    🇩🇪 Germany·2 Manufacturers

    Advena Limited

    Authorized representative
    🇲🇹 Malta·467 Manufacturers·13717 Devices

    Vingmed A/S

    Importer
    🇩🇰 Denmark·27 Manufacturers

    CRITICAL HEALTHCARE LIMITED

    Importer
    🇮🇪 Ireland·69 Manufacturers

    Shanghai International Holding Corp. GmbH(Europe)

    Authorized representative
    🇩🇪 Germany·637 Manufacturers·33064 Devices