BEUDAMED
    11 results · 38ms · 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 ×

    SYNTHES STERILE 3.5 MM AND 4.0 MM CANNULATED SCREWS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·June 7, 2018

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HWC·March 8, 2016

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·March 11, 2016

    Comfort EC710

    FDA 510(k)
    FDA Class 2 ·Radiology

    HARMONIC FOCUS CURVED SHEARS AND TORQUE WRENCH, HARMONIC BLUE HAND PIECE AND TEST TIP

    FDA 510(k)
    FDA Unclassified ·Unknown

    PERIGEE SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·February 12, 2013

    NASAL OXYGEN CANNULA

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code CAT·January 18, 2011

    UNKNOWN DEPUY FEMORAL COMP

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·July 29, 2014

    SCREW,FIXATION,BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·July 11, 2016

    Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part number 03.010.048) and the Thumb Screw for the Aiming Arm for Titanium Cannulated Tibial Nails-EX (part number 03.010.052). The Recon Locking Aiming Arm for Lateral Entry Femoral Recon Nails- EX is used when locking the Femoral Nail-EX. The Aiming Arm for Titanium (TI) Cannulated Tibial Nails-EX is used when locking the Tibial Nail-EX.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·March 25, 2015