BEUDAMED
    8 results · 17ms · 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.

    ESOPHAGEAL PROBE W/TEMP. INDICATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    iNSitu Hip System

    FDA UDI
    NEXTSTEP ARTHROPEDIX, LLC·00816127025907·Acetabular Reamer, Full Hemisphere, Crossbar, 53mm

    MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS

    FDA 510(k)
    FDA Unclassified ·Unknown

    PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    R SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·May 12, 2014

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·October 10, 2012

    ULTRACISION HARMONIC SCALPEL CURVED SHEARS, SCISSOR-GRIP HANDLE - 14CM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code GEI·January 10, 2008

    Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xcelera software. *********************************************************************************** Devices identified in the Field Safety Notice ( FSN MA-FCO79500316 ) QLAB Quantification Software. QLAB version 10.0, 10.1 and 10.1.1 with a2DQ and/or aCMQ plug-ins are affected. Catalog # 795041 and Part # 989605315491 Designed to view and quantify image data acquired on Philips Healthcare ultrasound products.

    FDA Enforcement
    Class II ·Terminated·Philips Ultrasound, Inc.·December 24, 2014