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

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    LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJUANA, ACCUSTIK THC

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    UNBRANDED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033558164·

    UNBRANDED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033558133·

    UNBRANDED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033558188·

    UNBRANDED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033558157·

    UNBRANDED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033558171·

    UNBRANDED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033558126·

    InTess C Cervical Cage System

    FDA UDI
    Kalitec Direct LLC·B07309K01406N0·Cervical Rasp, 15 x 12, 6mm, 0 Degree, No Taper

    UNBRANDED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033558140·

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0140060·Locking Cap, Temporary, Screw to Screw Distractor

    5C-ES CELL CONTROL, MODELS 7547191, 7547192

    FDA 510(k)
    FDA Class 2 ·Hematology

    TETHER ACFS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    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 IQ METER

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

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·March 10, 2011

    RFG-3C PLUS SYSTEM, 117V/60HZ

    FDA Adverse Event
    Malfunction ·COVIDIEN LP (VALLEYLAB)·Product code GXD·March 13, 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

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022