BEUDAMED
    13 results · 25ms · 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.

    CTM (CLINAC TREATMENT MONITOR)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776406332·Unique Freer Curette Combo 7 inches, Curette Si...

    Young Specialties

    FDA UDI
    Young Innovations, Inc.·00843471188255·.022 U/R STD. WELD SIZE #2

    TUBE, STERILE CONDUCTIVE CONNECTING

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Aquarius 8600

    FDA 510(k)
    FDA Class 2 ·Radiology

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    FDA Adverse Event
    Malfunction ·ALLERGAN·Product code LTI·October 1, 2012

    RESTORE

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 24, 2014

    PUMP MMT-511WWB PRDGM INSULIN BL EN

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·July 20, 2010

    Horizon Cardiology Hemo Component Schiller Argus Pro PB-1000 Monitor unit. Argus Pro PB 1000 firmware versions 2.41+M NIBP and 2.42.01+M. A programmable diagnostic computer intended for acquiring, digitizing, storing, displaying and reviewing hemodynamic data for use in hospital cardiac catheterization laboratories. The system is cleared for us with a component physiological data collection unit - the Schiller Argus Pro PB 1000 Monitor unit.

    FDA Recall
    Terminated ·McKesson Provider Technologies Medical Imaging Group·Product code DQK·April 15, 2010

    McKesson Cardiology ECG Management It is a software application designed to import, display, store, analyze, distribute and manage information related to ECG procedures of adult and pediatric patients from external ECG devices.

    FDA Recall
    Terminated ·McKesson Israel Ltd. 4 Nehoshet St., or Towers Bldg. B Tel Aviv Israel·Product code DQK·December 19, 2014

    McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management

    FDA Recall
    Open, Classified ·CHANGE HEALTHCARE CANADA COMPANY·Product code DQK·February 10, 2020

    Horizon Cardiology ECG Management This is a software application designed for use in various hospital departments to import, display, store, analyze, distribute, and process ECG procedures from resting ECG devices. It is also intended to provide analysis or reanalysis or testings ECGs and to provide preliminary data for editing and confirmation by an over-reading physician. Horizon Cardiology ECG Management may provide a serial comparison of ECG Data to facilitate the review of the patient's current ECG with previous ECG's of the same patient.

    FDA Recall
    Terminated ·McKesson Provider Technologies Medical Imaging Group·Product code DQK·June 16, 2010

    InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STERIS InnoWave Sonic Irrigators are intended to thoroughly clean (remove tissue, blood, and other contaminants from) a variety of reusable surgical instruments. The equipment provides sonic irrigation (ultrasonic cavitation) to both interior and exterior of lumened instruments.

    FDA Enforcement
    Class II ·Terminated·Steris Corporation·August 5, 2020