BEUDAMED
    12 results · 23ms · Sources: EU EUDAMED, US FDA

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    Pain Therapy Device

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    NA

    FDA UDI
    Synthes GmbH·10886982144454·3.0MM CANNULATED SCREW SHORT THREAD/38MM

    Medical Facets NC

    FDA UDI
    MEDICAL FACETS NC LLC·M933MDF2026380·3.0mm Cannulated Screw, Short Thread, 38mm

    Diamond Orthopedic, LLC

    FDA UDI
    DIAMOND ORTHOPEDIC, LLC·B551DMD2026380·3.0mm, Cannulated Screw, Short Thd., 38mm

    NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY KIT

    FDA 510(k)
    FDA Class 2 ·Neurology

    FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NON AC-POWERED PATIENT LIFT

    FDA Adverse Event
    Malfunction ·INVACARE REHABILITATION EQUIP·Product code FSA·October 27, 2014

    COOL PATH 7F, 1304-CP-7-25-L-AB (USA)

    FDA Adverse Event
    Death ·ST. JUDE MEDICAL, IRVINE·Product code OAD·August 8, 2011

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    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

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021