BEUDAMED
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    Filters FDA Recall × Status: Terminated × Clear all

    AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA

    FDA Recall
    Terminated ·Cardinal Health·Product code FYA·January 11, 2020

    AAMI 3 FABREINF SCRUB SURG GWN L NS, Gown. Item Code 90970NA

    FDA Recall
    Terminated ·Cardinal Health·Product code FYA·January 11, 2020

    AAMI 3 NON-REINF SURG GWN 3XL XLONG, Gown. Item Code 95995

    FDA Recall
    Terminated ·Cardinal Health·Product code FYA·January 11, 2020

    AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB

    FDA Recall
    Terminated ·Cardinal Health·Product code FYA·January 11, 2020

    AAMI 3 FABRNF SURG GWN XL 2 TOWELS, Gown. Item Code ASG9541

    FDA Recall
    Terminated ·Cardinal Health·Product code FYA·January 11, 2020

    AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB

    FDA Recall
    Terminated ·Cardinal Health·Product code FYA·January 11, 2020

    AAMI 3 NON-REINF SURG GWN XL 2 TWL, Gown Item Code ASG9545

    FDA Recall
    Terminated ·Cardinal Health·Product code FYA·January 11, 2020

    Normative Data Template CD for use with the I-Portal devices. Used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.

    FDA Recall
    Terminated ·Neuro Kinetics, Inc.·Product code GWN·November 21, 2013

    Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters, Cat. No's. 110-4B, 110-4G, 110-4H, 110-4L

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code GWN·July 9, 2014

    I-Portal NOTC and VNG; a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball, indicated for use as a diagnostic tool to assist trained clinicians in their analysis of vestibular disorders, which requires the separation of central vs. peripheral nervous system deficits.

    FDA Recall
    Terminated ·Neuro Kinetics, Inc.·Product code GWN·April 30, 2015

    Neuro Kinetics, Inc. (NKI) I-Portal NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.The OVAR test has not yet been cleared by the FDA, and until then can only be used as an investigational device.

    FDA Recall
    Terminated ·Neuro Kinetics, Inc.·Product code GWN·July 21, 2015

    Straumann Impression set for WN solid abutment H 4.00mm POM/ AI. Ref : 040.380 Kit Y4021. Intended to aid in the fabrication of dental prosthetics, and be used as a accessory with endosseous dental implants.

    FDA Recall
    Terminated ·Straumann Manufacturing Inc.·Product code NDP·June 15, 2010

    GEN*S SlideMaker, Barcode Label Specifications, GEN*S SM Intended Use, GEN*S Slide and Sample, Part Numbers 6605360, P/N 4237221, 4237212, and 4277299. Intended for use as an optional peripheral to the COULTER GEN*S System. Creates a blood smear on a clean microscope slide using a segment of the blood sample aspirated by the GEN*S System.

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code KPA·May 29, 2008

    COULTER GEN*S System, Part Number: 6605381, Beckman Coulter, Brea, CA. (Hematology analyzer)

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code GKL·April 18, 2007

    Coulter LH 700 Series and GEN S Hematology Analyzers 864.5220 Automated differential cell counter

    FDA Recall
    Terminated ·Beckman Coulter Inc·December 10, 2002

    Accuprobe Group B Streptococcus Culture Identification Test, Catalog Number 2820B, Batch Number 531379, Gen-Probe, Incorporated, San Diego, CA. 92121

    FDA Recall
    Terminated ·Gen-Probe Inc·Product code MDK·May 2, 2007

    Mycobacterium Tuberculosis Complex Culture Identification Test, 2860.

    FDA Recall
    Terminated ·Gen-Probe Inc·Product code LQF·December 30, 2008

    Gen-Probe AccuProbe Group B Streptococcus Culture Identification Test Kit, 2820.

    FDA Recall
    Terminated ·Gen-Probe Inc·Product code MDK·December 30, 2008

    Mycobacterium Avium Complex Culture Identification Test Identification Test Kit, 2835.

    FDA Recall
    Terminated ·Gen-Probe Inc·Product code LQF·December 30, 2008

    Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test, Catalog number 1001,

    FDA Recall
    Terminated ·Gen Probe Inc·Product code NDZ·June 11, 2004