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

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    IOB Warming Blankets

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Cascade

    FDA UDI
    CADWELL INDUSTRIES, INC.·00840067100424·ES5-100; Stim Splitter

    DM

    FDA UDI
    Guilin Kevin Peter Technology Co., Ltd.·06975384335939·5 pieces

    DM

    FDA UDI
    Guilin Kevin Peter Technology Co., Ltd.·16975384335936·5 pieces

    REACTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    INTELLIWAVE3

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    KP

    FDA UDI
    Guilin Kevin Peter Technology Co., Ltd.·16975384337114·6 pieces

    KP

    FDA UDI
    Guilin Kevin Peter Technology Co., Ltd.·06975384337117·6 pieces

    PRODIGY AUTOCODE

    FDA Adverse Event
    Injury ·OK BIOTECH CO., LTD.·Product code NBW·March 3, 2020

    AEQUALIS STEM FOR FRACTURE D.6.5 HA-COATED

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·January 5, 2026

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

    6000CMS

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·June 10, 2013

    INVISALIGN

    FDA Adverse Event
    Injury ·ALIGN·Product code NXC·October 15, 2014

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EGS·March 18, 2019

    SenTec Standard Starter Set with and without Service Gas (2 changers each) - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.

    FDA Enforcement
    Class II ·Terminated·SenTec AG·August 14, 2019

    BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    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