BEUDAMED
    8 results · 19ms · 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 Regulation: Us FDA ×

    Joline Kyphoplasty System Allevo

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BRIGHT SPINE GALILEO SPINAL SPACER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BENEVIEW T SERIES PATIENT MONITORS, MODELS BENEVIEW T8, T6 AND T5

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MIDWEST LOW SPEED ATTACHMENTS - CONTRA ANGLE SHEATH

    FDA Adverse Event
    Malfunction ·SIRONA DENTAL SYSTEMS GMBH·Product code EFB·April 20, 2023

    GALAXY INTRAVASCULAR ULTRASOUND SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - FREMONT (SUD)·Product code IYO·June 27, 2013

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·October 1, 2008

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    FDA Adverse Event
    Injury ·ALLERGAN·Product code LTI·July 27, 2011

    DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA. Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable). arrhythmia detection, ST Segment analysis, heart rate (HR) , respiration rate (RESP), temperature (TEMP), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG),impedance cardiograph (ICG), bispectral index (BIS), cardiac output (C.O.) and respiration mechanics (RM).

    FDA Enforcement
    Class II ·Terminated·Mindray DS USA, Inc. d.b.a. Mindray North America·December 19, 2012