BEUDAMED
    12 results · 24ms · 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 ×

    SPEED SHIFT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BACTI-SWAB

    FDA UDI
    REMEL, INC.·00848838018282·ACT II Dual Transport PK/10

    Fuji Cervical Plate System

    FDA UDI
    Altus Spine, LLC·B41711240221·Cortical-Cancellous Variable Angle Self-Drillin...

    CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 22mm

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665033540·

    Atoll™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981052546·4.0mm x 22mm Poly Screw Assm. The Atoll OCT Spi...

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 26, 2021

    AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIV

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    OSTEO-CABLE SLEEVE

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 17, 2013

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·September 27, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 14, 2011

    Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·April 8, 2015