BEUDAMED
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    CLASSIX CHEMICAL STERILIZATION INDICATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814558·GENUMEDI SAND SIZE IV

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964074592·Endo Carry-On Procedure Kit

    HEALTHLIGHT MICROCONTROLLER, MINIPRO, PRONEUROLIGHT, AND PRO UNIT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MEDIPRIME

    FDA 510(k)
    FDA Class 2 ·Radiology

    2.4MM VA LOCKING SCREW STARDRIVE 22MM

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·June 25, 2013

    VA LOCKSCR Ø2.4 SELF-TAP L18 TAN

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HRS·July 15, 2013

    BAXANO IO-FLEX SYSTEM

    FDA Adverse Event
    Other ·BAXANO, INC.·Product code HAE·July 2, 2012

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·May 9, 2013

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 19, 2014

    OXIMAX N-595 PULSE OXIMETER

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY TYCO HEALTH·Product code DQA·May 3, 2011

    BAXANO IO-FLEX SYSTEM

    FDA Adverse Event
    Other ·BAXANO, INC.·Product code HAE·July 2, 2012

    2.4MM TI LOCKING SCR SLF-TPN WITH STARDRIVE RECESS 18MM

    FDA Adverse Event
    Malfunction ·SYNTHES BETTLACH·Product code HWC·June 21, 2017

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HWC·December 24, 2015

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·July 30, 2015

    2.4MM TI LOCKING SCR SLF-TPN WITH STARDRIVE RECESS 18MM

    FDA Adverse Event
    Malfunction ·SYNTHES BETTLACH·Product code HWC·June 21, 2017

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HRS·October 24, 2015

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·August 6, 2025

    The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump Assembly, Product Code SC6053

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·March 10, 2021

    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