BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement

    FDA 510(k)
    FDA Class 2 ·Radiology

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707014805·CALIBRA 1ST MOL BANDS W/G8325-03 n.UL 26

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00842528128060·3.0 X 26mm Cannulated Headless Screw, T10

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100288·SAUER PREMATURE INFANT SPECULUM 2MM

    BD ULTRA-FINE II SHORT NEEDLE INSULIN SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·August 5, 2021

    KOWA NONMYD 7, KOWA NONMYD A-D

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ELECTRO SENSOR -BODY COMPOSITION

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FLOGARD

    FDA Adverse Event
    Malfunction ·SHARP CORPORATION OSAKA JAPAN·Product code FRN·October 8, 2014

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·July 7, 2011

    CAPSUREFIXNOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC SINGAPORE OPERATIONS·Product code DTB·June 8, 2013

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 2014

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

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

    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