BEUDAMED
    14 results · 28ms · Sources: EU EUDAMED, US FDA

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    WaveForm L System, WaveForm TO System, WaveForm TA System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    D-LISH

    FDA UDI
    YOUNG DENTAL MANUFACTURING I, LLC·00302730002195·Young D-Lish 5% Sodium Fluoride Varnish, 0.40mL...

    D-Lish Mint Surprise Varnish 200

    FDA UDI
    YOUNG DENTAL MANUFACTURING I, LLC·10302732134204·

    Votion

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730007797·Votion 018 MC LR4 G/O -12T 2A 0O (10PK)

    Votion®

    FDA UDI
    Ortho Organizers, Inc.·00190707113483·Votion .018 MC LR4 G/O -12T 2A 0O (10PK) VOTION

    RNARETAIN

    FDA 510(k)
    FDA Class 2 ·Immunology

    CHEMWELL, ALSO KNOWN AS PROJECT 2900

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GLUCOMETER ELITE 4 DATE

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·January 20, 2006

    ENSITE CLASSIC SYSTEM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code DQK·February 9, 2010

    INRATIO PT/INR TEST STRIPS

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·October 23, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011

    PRECISION®

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 9, 2013

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017

    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