BEUDAMED
    13 results · 28ms · Sources: EU EUDAMED, US FDA

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    LATEXX MANUFACTURING NON-CHLORINATED, POLYMER COATED, POWDER-FREE RUBBER LATEX EXAMINATION GLOVE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0140070·T-Handle, T30, Locking Cap Adjuster

    InTess C Cervical Cage System

    FDA UDI
    Kalitec Direct LLC·B07309K01408N0·Cervical Rasp, 15 x 12, 8mm, 0 Degree, No Taper

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033562765·

    XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP

    FDA 510(k)
    FDA Class 2 ·Neurology

    BIPOLAR PENCIL, MODEL 3901-002, 3900-002

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

    GOOD SAM CINCINNATI OH 1

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA, INC.·Product code DWE·December 11, 2008

    HEARTSINE SAMARITAN 300P AND PAD-PAK K014067

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·July 19, 2018

    HEARTSINE SAMARITAN 300P AND PAD-PAK K014067

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·March 7, 2018

    OT VERIO TEST STRIPS

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013

    FREESTYLE NAVIGATOR

    FDA Adverse Event
    Malfunction ·Product code MDS·March 10, 2011

    SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES, PR·Product code DYG·March 14, 2008

    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