BEUDAMED
    10 results · 18ms · 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.

    POLYSTAN HEART LUNG MACHINE SYS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ultraverse® 018

    FDA UDI
    Bard Peripheral Vascular, Inc.·00801741054624·Ultraverse® 018 PTA Balloon Dilatation Catheter...

    Bioplate®

    FDA UDI
    Bioplate, Inc.·M3848130340·Boxcar Plate - Ø1.9 mm - 4 hole - 11 x 11 mm

    Bioplate®

    FDA UDI
    Bioplate, Inc.·M384813034CP1·Boxcar Plate - Ø1.9 mm - 4 hole - 11 x 11 mm

    Bioplate®

    FDA UDI
    Bioplate, Inc.·M384813034US0·Boxcar Plate - Ø1.9 mm - 4 hole - 11 x 11 mm

    MODIFICATION TO: THERMACOOL IIA

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    GE INNOVA SOLID STATE XRAY IMAGER FLUROSOPIC X RAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·May 15, 2014

    ATTAIN OTW

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012

    REPAIR CORE IMPACTION DRILL

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·August 12, 2010