BEUDAMED
    18 results · 11ms · Sources: EU EUDAMED, US FDA

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    GREER M. FAENI, 0.25 mL 20 MG/ML, Item: K6, Analyte Specific Reagent, HYPERSENSITIVITY PNEUMONITIS test system, gel diffusion kit for demonstrating precipitating antibodies.

    FDA Recall
    Terminated ·Greer Laboratories, Inc.·Product code DGW·October 25, 2022

    GREER DIA - KIT ANTIGEN M. FAENI, 2.0mL 20 MG/ML, Analyte Specific Reagent, Item: K62, HYPERSENSITIVITY PNEUMONITIS test system, gel diffusion kit for demonstrating precipitating antibodies.

    FDA Recall
    Terminated ·Greer Laboratories, Inc.·Product code DGW·October 25, 2022

    Microwave Ovens, Model Number DG-2

    FDA Recall
    Terminated ·Duke Manufacturing Co.·Product code RCS·May 12, 2010

    Radiofrequency Grounding Pad, REF RF-DGP-L

    FDA Enforcement
    Class II ·Terminated·Abbott Medical·December 18, 2019

    DERMALIFE Takara. Part #E30006-02 - Takara; Renew 2G, w/Pedestal. This is the Spa Jet product re-named for Takara Belmont, our New Jersey based distributor, identical to Part #E30006-01 other than the stickers on the unit.

    FDA Recall
    Terminated ·Sybaritic, Inc·Product code IMB·June 22, 2007

    GE Healthcare Revolution XR/d; GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 Model numbers: 2259988-2 & 2351505. The Revolution XR/d Digital Radiographic Imaging System is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen system in all general-purpose diagnostic procedures. This device is not intended for mammographic applications.

    FDA Enforcement
    Class II ·Terminated·General Electric Med Systems LLC·June 20, 2012

    Dow Corning Silastic brand Medical Adhesive Silicone, Type A, non-sterile, 57 gram tube; material numbers 3242901 (100 tubes) and 3242897 (6 tubes).

    FDA Recall
    Terminated ·Dow Corning Corp.·September 5, 2003

    GE Medical Systems CardioLab System, electrophysiological data system, Software Version 6.5 2021423-016 Revision D GE Medical Systems, Information Technologies, Inc. 8200 West Tower Avenue, Milwaukee, WI 53223 USA.

    FDA Recall
    Terminated ·General Electric Medical Systems Information Technology·Product code DQK·February 16, 2007

    Acetabular Pressurizer; single use and six units per box. The Acetabular Pressurizer 0206-522-000 is an accessory to the Advanced Cement Mixer (ACM). The Acetabular Pressurizer Tiplet P/N 0206-522-012 is sealed in a two pouches, sterilized, and labeled as part number 0206-522-000. This Acetabular Pressurizer is an accessory used to pressurize the cement applied to the prosthesis to be implanted during the surgery. The Acetabular Pressurizer is an injection molded component made with resin material DOW HDPD 10462N which is a rigid plastic once it is molded.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·November 20, 2013

    DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads) The product is used during ablation surgical procedures.

    FDA Enforcement
    Class II ·Terminated·Nellcor Puritan Bennett Inc. (dba Covidien LP)·September 5, 2012

    GE Medical Systems Mac-Lab System, cardiac catheterization data system. Software Version 6.5 2021423-015 Revision D GE Medical Systems, Information Technologies, Inc., 8200 West Tower Avenue, Milwaukee, WI 53223 USA.

    FDA Recall
    Terminated ·General Electric Medical Systems Information Technology·Product code DQK·February 16, 2007

    GE Healthcare Revolution XR/d; GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 Model numbers: 2259988-2 & 2351505. The Revolution XR/d Digital Radiographic Imaging System is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen system in all general-purpose diagnostic procedures. This device is not intended for mammographic applications.

    FDA Recall
    Terminated ·General Electric Med Systems LLC·Product code MQB·May 31, 2006

    IgE Calibrator Series

    FDA Recall
    Terminated ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code DGC·September 7, 2016

    Immunoglobulin G is an in vitro diagnostic assay for the quantitative determination of immunoglobulin G in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 700 nm, which correlates with the concentration of immunoglobulin G in the sample.

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code DEW·May 16, 2018

    ST-AIA PACK IGE II; Part Number: 025295 Assay, Allergy

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code DGC·March 5, 2018

    Immulite 2000 and Immulite 2500 digital Fluidics PC Board, Part Number 450116-0002. Performs chemiluminescent immunoassays using serum, plasma, and/or urine for in vitro diagnostic testing.

    FDA Recall
    Terminated ·Siemens Medical Solutions Diagnostics·Product code DGC·January 5, 2009

    SYNCHRON System(s) Immunoglobulin A (Ig-A) Reagent, Part Number: 467920

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code DEW·June 28, 2010

    IMMAGE IgM Reagent Part No.: 447610

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code DEW·June 6, 2003