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

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    BBL Port A Cul tubes with Swabs Sterile Pack, catalog number 221607. For patient sample collection.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·June 17, 2015

    C-Section Pack, Kit number 002643-10, 002643-9, and AMS4449 convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Shoulder Arthroscopy Pack, Kit number 002648-15, 002648-16, AMS2496, AMS2496(A, AMS2609, PSS2209(A, and PSS2209(B. convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Laparoscopy Kit, Kit number PSS1038(A and PSS1038(B convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)

    FDA Enforcement
    Class II ·Terminated·Maquet Datascope Corp - Cardiac Assist Division·March 4, 2015

    Ortho Kit, Kit number PSS1039(A and PSS1039(B convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971

    FDA Enforcement
    Class II ·Terminated·ArthroCare Corporation·September 30, 2020

    VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho Clinical Diagnostics. For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JJE·November 19, 2014

    GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner.

    FDA Recall
    Terminated ·GE Healthcare·Product code JAK·December 19, 2014

    VITROS 5600 Integrated System, Catalog Number 6802413, IVD --- Ortho Clinical Diagnostics. For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JJE·November 19, 2014

    Invacare Perfecto 2 V Oxygen Concentrator The finished device is packaged as a single unit. The service part contains a single pair of sieve beds; one pair of sieve beds is used in a single finished device. Intended to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve.

    FDA Enforcement
    Class II ·Terminated·Invacare Corporation·December 17, 2014

    pH 7.0 Buffer Solution Pint and Quart Bottles, Part Number 02.0030 for Pints and 02.0031 for Quarts. Packaged in Plastic Bottles. Can be sold individually or in cartons with 6 bottles per box (for quart bottles only). Used in the hemodialysis setting to calibrate pH meters.

    FDA Enforcement
    Class II ·Terminated·Mesa Laboratories, Inc.·November 13, 2013

    VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Catalog Number 6802445, IVD --- Ortho Clinical Diagnostics. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods).

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JJE·November 19, 2014

    SAM Junctional Tourniquet (SJT) Auxiliary, Model SJT 102 and SJT 112. The SJT models specific intended uses are to control difficult bleeds in the inguinal area and to immobilize a pelvic fracture.

    FDA Enforcement
    Class II ·Terminated·Sam Medical Products·November 5, 2014

    Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD for In Vitro Diagnostic use; an antibody class capture enzyme immunoassay for the detection of IgM antibodies to T. pallidum as an aid to the identification of active syphilis in human serum.

    FDA Recall
    Terminated ·Clark Laboratories, Inc. (dba, Trinity Biotech USA)·Product code LIP·November 17, 2014

    Focal Sim radiation therapy treatment planning system

    FDA Recall
    Terminated ·Elekta, Inc.·Product code MUJ·December 19, 2014

    Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1.

    FDA Recall
    Terminated ·Sunrise Medical (US) LLC·Product code IOR·December 19, 2014

    Quickie Q7 Adult Rigid Wheelchair Model EIR4.

    FDA Recall
    Terminated ·Sunrise Medical (US) LLC·Product code IOR·December 19, 2014

    CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color direct immunofluorescence reagent for enumerating percentages of mature human suppressor/cytotoxic (CD8+) lymphocytes in erythrocyte-lysed whole blood or peripheral blood mononuclear cell suspensions.

    FDA Recall
    Terminated ·BD Biosciences, Systems & Reagents·Product code GKL·December 19, 2014

    Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Model: 704060/706037

    FDA Recall
    Terminated ·Philips Medical Systems, Inc.·Product code KPR·August 19, 2014