BEUDAMED
    57 results · 13ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    GE Healthcare Signa, Discovery and Optima. Signa HDe 1.5T; Signa Infinity TwinSpeed MR System, 1.5T Infinity TwinSpeed, Signa Lx; Signa Infinity MR System with EXCITE Technology, Excite II, Signa Excite 1.5T Expert; Signat 3T Infinity with Excite; Signa 3.0T with EXCITE; Signa Excite 1.5T and Signa Excite 3T, Signa Excite HD, Signa HD 1.5T and Signa HD 3.0T; Signa HDx; Signa HDxt; Signa Vibrant; Signa HDi; Signa Horizon Cx aka MR/I; Discovery MR450; Discovery MR750; Optima MR450w; Signa Cvi, and Signa Nvi. The Optima MR45Ow is a whole body magnetic resonance scanner designed to support high resolution and high signal-to-noise ratio images in short exam times. it is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique anatomical images, spectroscopic data, parametric maps, or dynamic images of the structures or functions of the entire body. The indication for use includes, but is not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Optima MR450w reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and spectra, when interpreted by a trained physician yield information that may assist in diagnosis.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code IWE·September 15, 2011

    BioRad BioPlex 2200 Software, for BioPlex 2200 Instrument, an automated immunodiagnostic analyzer, Bio-Rad Laboratories, Inc., Hercules, CA 94547

    FDA Recall
    Terminated ·Bio-Rad Laboratories Inc·Product code NVI·November 13, 2007

    CDLCAM, First-Pass Radionuclide Angiography Camera System, Model 70-500101, with operating Software Version B1A, marketed by CDL Medical Tech.

    FDA Recall
    Terminated ·GVI Technology Partners·Product code IYX·January 16, 2004

    AVI Sterile Impad Rigid Sole Foot Cover, Right Foot Product Code:6066

    FDA Recall
    Terminated ·Product code JOW·August 11, 2010

    AVI Sterile Impad Rigid Sole Foot Cover, Left Foot Product Code:6067

    FDA Recall
    Terminated ·Product code JOW·August 11, 2010

    CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label, 100 per case --- Manufactured for: Dynarex Corporation - Made in China. Used as a physical barrier for mouth to mouth resuscitation.

    FDA Recall
    Terminated ·Dynarex Corporation·Product code CBP·July 2, 2014

    dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only Product Usage:containers for sample collection

    FDA Recall
    Terminated ·Dynarex Corporation·Product code NNI·March 3, 2016

    BVI Visitec Soft Tip Cannula, 0.8MM .50 x 33mm (25G x 1.3 in). The BVI Soft Tip Cannula is intended to irrigate and/or aspirate ophthalmic solutions and liquids in or out of the eye, and remove materials where appropriate (e.g. retinal, subretinal procedures).

    FDA Enforcement
    Class II ·Terminated·Beaver Visitec·April 3, 2019

    Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number LC4203 (Reorder No. 21-0341-01) 105 inch length/267 cm, 25ml priming volume, 20 drops/ml, 2 needleless Injection sites.

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code FPA·December 3, 2004

    Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number 8C390 (Reorder No. 21-0325-01) 121 inch length/307 cm, 28ml priming volume, 20 drops/ml, 0 injection sites.

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code FPA·December 3, 2004

    Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number 8C220 (Reorder No. 21-0323-01) 107 inch length/272 cm, 26ml priming volume, 20 drops/ml, 1 standard injection site.

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code FPA·December 3, 2004

    Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number CJ4303 (Reorder No. 21-0313-01)110 inch length/279 cm, 16.5ml priming volume, 20 drops/ml, 3 SureSite Prepierced injection sites.

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code FPA·December 3, 2004

    Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number CF4203 (Reorder No. 21-0340-01) 105 inch length/267 cm, 25ml priming volume, 60 drops/ml, 2 SureSite Prepierced Injection Sites.

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code FPA·December 3, 2004

    Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number CC4203 (Reorder No. 21-0339-01) 105 inch length/267 cm, 25ml priming volume, 20 drops/ml, 2 SureSite Prepierced Injection Sites.

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code FPA·December 3, 2004

    GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models: 1. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 1012, UDI: (01)07090038460092 2. Gentian C E Calibrator Kit, 6 x 1 mL, REF 1051, UDI: (01)07090038460108 3. Gentian C E, BCI Ref: A52763, Cystatin C calibrator Kit, 6 x 1 mL, REF 1051, (01)17090038460037 4. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 8012 (Not distributed in US)

    FDA Recall
    Terminated ·Gentian AS Bjornasveien·Product code NDY·September 2, 2020

    ST-AIA PACK Cystatin C; Part Number: 025217 Assay, Kidney Marker

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

    Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number I8C820 (Reorder No. 21-0346-25) Primary Administration Set described as 105 inch length/267 cm, 25ml priming volume, 20 drops/ml and 1 Injection site.

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code FPA·December 3, 2004

    Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number NJ4303 (Reorder No. 21-0426-01) described as 110 inch length/279 cm, 16.5ml priming volume, 20 drops/ml, 3 Luer-Activated Valve injenction Sites Burette set.

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code FPA·December 3, 2004

    Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number AK2304 (Reorder No. 21-0308-01) 118 inch length/300 cm, 19ml priming volume, 60 drops/ml, 3 standard injection sites and 0.22 micron air-eliminating filter.

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code FPA·December 3, 2004

    Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number RC4106 (Reorder No. 21-0402-25) Primary Administration Set described as 105 inch length/267 cm, 25ml priming volume, 20 drops/ml and 1 Needless Injection site.

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code FPA·December 3, 2004