BEUDAMED
    10 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.

    OSTEOGEN (HA RESORB)

    FDA 510(k)
    FDA Class 2 ·Dental

    SwishPlus® Implant

    FDA UDI
    IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307106081·Ø3.7 x 8 Platform 3.5mmD

    Instrument Case

    FDA UDI
    KATENA PRODUCTS, INC.·00841668111062·INSTRUMENT CASE MEDIUM ALUMINUM

    POLARIS 5.5 IMPLANTS

    FDA Adverse Event
    Malfunction ·EBI, LLC·Product code MNH·November 10, 2010

    FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+)

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

    Antimicrobial Silicone PHMB Foam Wound Dressing

    FDA 510(k)
    FDA Unclassified ·Unknown

    YALE NH TT VISION SYS GBS

    FDA Adverse Event
    Other ·GISH BIOMEDICAL, INC.·Product code OEZ·December 3, 2010

    TENDRIL ST

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 9, 2014

    EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYS.

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code MAF·April 18, 2006

    EndoVive 3s Low Profile Balloon Kits Part Number: M00549600 (XMD P/N 70-0050-G24) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

    FDA Enforcement
    Class II ·Terminated·Xeridiem Mediem Medical Devices Inc·March 2, 2016