BEUDAMED
    16 results · 22ms · 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.

    Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P28, P29, P30, P20-A, P20-B, P20-C, P20-D)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Oph. Cystotomes

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113721·CYSTOTOME CURVED 27GA

    ARTICUL/EZE

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295128922·ARTICUL/EZE TRIAL BALL GROOVED 26mm DIA +7

    N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN

    FDA 510(k)
    FDA Class 2 ·Immunology

    Franz Zirconia Dental Crown

    FDA 510(k)
    FDA Class 2 ·Dental

    ITST®

    FDA UDI
    Zimmer, Inc.·00889024043558·

    M/DN®

    FDA UDI
    Zimmer, Inc.·00889024043534·

    M/DN®

    FDA UDI
    Zimmer, Inc.·00889024043565·

    M/DN®

    FDA UDI
    Zimmer, Inc.·00889024043541·

    GE OEC 2600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·December 9, 2008

    OT ULTRALINK METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·September 19, 2011

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 29, 2013

    INNOVO

    FDA Adverse Event
    Injury ·NOVO NORDISK A/S -MEDICAL SYSTEMS·Product code FMF·June 1, 2006

    Cortical Screw for M/DN Intramedullary Fixation. Metaphyseal/Diaphyseal Nail System, Orthopedic surgical device.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·June 10, 2015

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014