BEUDAMED
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    CANDELA SMOOTHBEAM LASER SYSTEM

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

    EZ2C

    FDA UDI
    FGX INTERNATIONAL INC.·00193033521052·

    EZ2C

    FDA UDI
    FGX INTERNATIONAL INC.·00193033521007·

    EZ2C

    FDA UDI
    FGX INTERNATIONAL INC.·00193033520994·

    EZ2C

    FDA UDI
    FGX INTERNATIONAL INC.·00193033521021·

    EZ2C

    FDA UDI
    FGX INTERNATIONAL INC.·00193033520987·

    EZ2C

    FDA UDI
    FGX INTERNATIONAL INC.·00193033521069·

    MEDLINE STERISET STERILIZATION CONTAINER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NONE

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code LFR·April 17, 2015

    AXIOM ARISTOS VX PLUS

    FDA Adverse Event
    Injury ·SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD·Product code MQB·April 7, 2021

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·March 20, 2013

    LOCKING PLATE, SAGITTAL SPLIT, 12MM BAR, 6 HOLE, O

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS FREIBURG·Product code JEY·February 4, 2011

    DEEP BRAIN STIMULATION LEAD KIT

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·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

    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