BEUDAMED
    999 results · 132ms · 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.

    DATA MEDICAL ASSOCIATES CALCIUM PLUS REAGENT

    FDA Adverse Event
    Injury ·DATA MEDICAL ASSOCIATES, INC.·Product code CJY·November 20, 1997

    DMA ONE-SHOTS HDL PRECIPITATING REAGENT

    FDA Adverse Event
    Injury ·DATA MEDICAL ASSOCIATES, INC. (DMA)·Product code LBS·December 5, 1996

    Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Product is manufactured and distributed by Philips Healthcare Informatics, Inc. Foster City, CA IntelliSpace PACS are image management systems intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. iSite supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, DX, DR, RE, RT, MG, SC, VL, as well as hospital/radiology information systems.

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare Informatics, Inc.·November 20, 2013

    ELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead. Once the data is acquired, it can be analyzed, reviewed, stored, printed or transmitted. It is a device primarily intended for use in hospitals, but may be used in medical clinics and offices of any size.

    FDA Enforcement
    Class II ·Terminated·Mortara Instrument, Inc·June 24, 2015

    Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Product is manufactured and distributed by Philips Healthcare Informatics, Inc. Foster City, CA IntelliSpace PACS are image management systems intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. iSite supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, DX, DR, RE, RT, MG, SC, VL, as well as hospital/radiology information systems.

    FDA Recall
    Terminated ·Philips Healthcare Informatics, Inc.·Product code LLZ·October 14, 2013

    BECKMAN TOTAL BILIRUBIN TRIGGERED (TB-T) KIT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code CIG·July 16, 2012

    HEMOLUNG RAS

    FDA Adverse Event
    Injury ·ALUNG TECHNOLOGIES, INC.·Product code QOH·January 19, 2023

    DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data.

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code NSX·July 16, 2012

    DataCare POC is an information management system that provides data management functionality for managing point-of -care testing data.

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code NSX·July 16, 2012

    HEMOLUNG RAS

    FDA Adverse Event
    Injury ·ALUNG TECHNOLOGIES, INC.·Product code DQR·January 18, 2023

    SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM

    FDA Adverse Event
    Injury ·SHOCKWAVE MEDICAL, INC.·Product code QMG·April 14, 2023

    SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM

    FDA Adverse Event
    Death ·SHOCKWAVE MEDICAL, INX.·Product code QMG·April 13, 2023

    Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS AmpliPrep instrument, COBAS TaqMan analyzer, COBAS TaqMan 48 analyzer, COBAS AMPLICOR analyzer, and Cobas p 630 instrument for sample preparation, amplification and detection of PCR (Polymerase Chain Reaction) molecular diagnostic analytes.

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code NSX·July 16, 2012

    SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM

    FDA Adverse Event
    Death ·SHOCKWAVE MEDICAL, INC.·Product code QMG·April 18, 2023

    SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM

    FDA Adverse Event
    Injury ·SHOCKWAVE MEDICAL, INC.·Product code QMG·April 18, 2023

    INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 24FR DILATOR

    FDA Adverse Event
    Malfunction ·AVANOS MEDICAL INC.·Product code KGC·December 19, 2018

    HEMOLUNG RAS

    FDA Adverse Event
    Injury ·ALUNG TECHNOLOGIES, INC.·Product code QOH·January 19, 2023

    HEMOLUNG RAS

    FDA Adverse Event
    Injury ·ALUNG TECHNOLOGIES, INC.·Product code QOH·February 24, 2023

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JLS·January 31, 2012

    UNICEL® DXI WASH BUFFER II

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code LDT·February 9, 2012