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

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    RUBELLACOL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Generic Buccal Tubes

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746153846·DB TUBE INCONEL LR 2ND MOL 022 T=0 R=0 3.5MM

    HARDYDISK CEFONICID, 30 MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MODIFICATION TO EXCITE

    FDA 510(k)
    FDA Class 2 ·Dental

    DEPUY ASR XL FEM IMP SIZE 46

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·April 2, 2013

    RESTORIS MCK ONLAY TIBIAL INSERT

    FDA Adverse Event
    Injury ·MAKO SURGICAL·Product code HSX·January 18, 2011

    ICY HOT HEAT THERAPY

    FDA Adverse Event
    Injury ·CHATTEM, INC.·Product code IMD·April 17, 2008

    Toshiba Excelart VANTAGE Model MRT-1503, Magnetic Resonance Imaging Systems, Regulation Number 21 CPR 892.1000, Regulatory Class II, Product Code 90-LNH and was cleared with K032490

    FDA Recall
    Terminated ·Toshiba American Med Sys Inc·Product code LNH·October 12, 2005

    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

    The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018