BEUDAMED
    13 results · 27ms · Sources: EU EUDAMED, US FDA

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    IMAGECAST PACS

    FDA 510(k)
    FDA Class 2 ·Radiology

    Sterilance Press Pressure Activated Safety Lancet

    FDA UDI
    SteriLance Medical (Suzhou) Inc.·16945630108775·Sterilance Press Pressure Activated Safety Lanc...

    Sterilance Press Pressure Activated Safety Lancet

    FDA UDI
    Sterilance Medical (Suzhou) Inc.·16945630111973·

    Sterilance Press Pressure Activated Safety Lancet

    FDA UDI
    SteriLance Medical (Suzhou) Inc.·16945630108829·Sterilance Press Pressure Activated Safety Lanc...

    Sterilance Press Safety Lancet 26G 1.8mm

    FDA UDI
    Sterilance Medical (Suzhou) Inc.·16945630123099·

    3.0T 8 CHANNEL NEUROVASCULAR (NV) ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    X-SCRIBE II

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVY·April 11, 2013

    VITALITY

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 13, 2011

    PERCLOSE PROGLIDE 6FR SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR - REDWOOD CITY·Product code MGB·May 27, 2008

    ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    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

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021