BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    Exactech® Equinoxe® Laser Cage Glenoid

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Distal Ulna Plate

    FDA UDI
    I.T.S. GmbH·09120047306710·Distal Ulna Plate, 6-Hole, Right, Small

    GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ALIVECOR HEART MONITOR FOR IPHONE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OT PING METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 30, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 15, 2011

    STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK

    FDA Adverse Event
    Injury ·SYNTHES·Product code JDQ·July 9, 2013

    Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057, 712062 Product Usage: Universal RAD Applications

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare Inc.·June 26, 2013

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system 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.·August 5, 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

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023