BEUDAMED
    16 results · 20ms · 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 ×

    ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 2

    FDA 510(k)
    FDA Class 2 ·Dental

    Z Liquid HT C4-C 100ml

    FDA UDI
    ARGEN CORPORATION, THE·D818121824·Dental porcelain/ceramic restoration kit

    EXIN

    FDA UDI
    FOREMOUNT ENTERPRISE CO., LTD.·04719871893449·Standard cushion mask without valve #4

    NA

    FDA UDI
    Smith & Nephew, Inc.·03596010064837·4.0MM PARTIALLY THREADED ...

    CAIMAN DISP. INSTR. NON ARTICUL. D:5/360MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG AND CO. KG·Product code GEI·December 12, 2014

    DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM, MODELS 1010102-38,1010102-56,1010102-80,1010103-38,1010103-56, 101010

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

    AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER

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

    ANGEL SYSTEM WITH ASPIRATION KIT W/ ACDA

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code ORG·March 5, 2019

    ARTHREX ANGEL SYSTEM WITH ASPIRATION KIT

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code ORG·May 1, 2019

    ACRYSOF

    FDA Adverse Event
    Injury ·ALCON LABORATORIES IRELAND LTD.·Product code HQL·May 15, 2013

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·September 26, 2014

    ACCESS 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code CGN·May 20, 2011

    THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5X4MM

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code GWO·April 16, 2018

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024