BEUDAMED
    201 results · 14ms · 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 FDA Recall × Status: Terminated × Clear all

    SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory information system to be used in a medical research or clinical laboratory.

    FDA Recall
    Terminated ·SCC Soft Computer·Product code JQP·May 20, 2014

    G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7. Product Usage: G7 Variant Elution Buffer HiS No 1. (M) is one of the buffers used on Tosoh Automated Glycohemoglobin Analyzer HLC 723G7.

    FDA Recall
    Terminated ·Tosoh Bioscience, Inc.·Product code LCP·February 10, 2015

    WEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of cardiac structure; i.e., stimulation and recording only. Catalog No: 01085413

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code DRF·April 17, 2015

    The ABL800 Model#:All

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CHL·January 26, 2017

    ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin, and oximetry in whole blood.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CHL·January 26, 2017

    ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CHL·July 5, 2012

    Soft Query Results Reporting Versions 2.2.0.6.3 and 2.2.0.7.1. SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760. Soft Query Results Reporting version 2.2.0.6.3 was released for General Availability on 09/11/03. Soft Query Results Reporting version 2.2.0.7.1 was released for General Availability on 01/08/04.

    FDA Recall
    Terminated ·SCC Soft Computer·Product code LNX·November 30, 2004

    ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the labeling, ensuring control of the appropriate HORIBA ABX SAS methods on the ABX PENTRA chemistry analyzers. Each control level is provided in one vial of 10 ml. The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.

    FDA Recall
    Terminated ·Horiba Instruments, Inc dba Horiba Medical·Product code JJY·December 18, 2013

    DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only. Interphalangeal implant.

    FDA Recall
    Terminated ·In2Bones, SAS 28 Chemin Du Petit Bois Ecully France·Product code HWC·March 9, 2015

    DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only. Interphalangeal implant.

    FDA Recall
    Terminated ·In2Bones, SAS 28 Chemin Du Petit Bois Ecully France·Product code HWC·March 9, 2015

    Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00 Product Usage: The CardioCall event recorder is worn by the patient to record a short period of electrocardiogram which can be sent to his physician.

    FDA Recall
    Terminated ·Spacelabs Healthcare Inc·Product code DXH·September 3, 2015

    Regius Model 370 Digital Radiography Konica Minolta

    FDA Recall
    Terminated ·Konica Minolta Medical Imaging USA, Inc.·Product code MQB·July 14, 2006

    UMP Personal Sentry Deluxe Pull String Monitor, Model #91650. The firm on the label is Universal Medical Products, Lincoln, NE. Designed to sound an alarm when a patient exceeds his or her safe range of movement from a wheelchair, chair, or bed.

    FDA Recall
    Terminated ·Stanley Security Solutions, Inc.·Product code KMI·December 6, 2011

    The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter. The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CHL·July 5, 2012

    The ABL software version 6.12 for the ABL800 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter. The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CHL·July 5, 2012

    LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healthcare Products LLC, Dothan, AL 96303. A sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections).

    FDA Recall
    Terminated ·Ansell Healthcare Products LLC·Product code HIS·January 14, 2013

    Durex Pleasure Pack . 3 ultra fine lubricated latex condoms 12 ultra fine lubricated latex condoms 24 Ra fine lubricated latex condoms 3 ct UPC 3-02340-30042-04-1 3 ct - Walmart UPC 02340-70042-04 12ct - UPC 3-02340-30274-08-6 24 ct - UPC 302340-302190-04 (contacting firm for label)

    FDA Recall
    Terminated ·Reckitt Benckiser LLC·Product code HIS·November 22, 2016

    Lifestyles Pleasure Collection 30 Premium Lubricated Condoms Assortment of Ultra Sensitive, Flavors and Colors, Skyn, Thryll, Thyn, and Ultra Thin. UPC 0-70907-02625-0.

    FDA Recall
    Terminated ·Ansell Healthcare Products LLC·Product code HIS·November 5, 2012

    Lubricated Latex Condom. Labeled in part: "COMING TOGETHER IN DC", Distributed by Global Protection Corp., #12 Channel Street, Boston, MA

    FDA Recall
    Terminated ·Global Protection Corp.·Product code HIS·September 11, 2007

    Assorted colored and flavored condoms: LifeStyles Luscious Flavors, Prime Assorted Colors, Contempo Luscious Flavors, Contempo Intensity Assorted Colors

    FDA Recall
    Terminated ·Ansell Healthcare Inc·Product code HIS·November 25, 2002