BEUDAMED
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    MODIFICATION TO CORAL SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RABEA 5°

    FDA UDI
    SIGNUS Medizintechnik GmbH·04047844000694·The basic shape of the NUBIC and RABEA devices ...

    RABEA 0°

    FDA UDI
    SIGNUS Medizintechnik GmbH·04047844000540·The basic shape of the NUBIC and RABEA devices ...

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756140119·OEM Foley Catheter

    General Instrument

    FDA UDI
    ALPHATEC SPINE, INC.·00840180505601·TLIF Shavers

    POWDERED VINAL EXAM GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    KWIKKMODEL

    FDA 510(k)
    FDA Class 2 ·Dental

    SAF-T-INTIMA

    FDA Adverse Event
    Malfunction ·BD SUZHOU (MDS)·Product code FOZ·August 19, 2025

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 7, 2025

    NDEHP PRIMARY PLUM PREPIERCED Y

    FDA Adverse Event
    Malfunction ·HOSPIRA HOLDINGS DE COSTA RICA LTD.·Product code FRN·April 25, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 26, 2013

    DBS LEAD

    FDA Adverse Event
    Malfunction ·MPROC, VILLALBA·Product code MHY·April 22, 2011

    ONE TOUCH ULTRA TEST STRIPS #100

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·July 24, 2008

    Alcon Custom Ophthalmic Surgical Procedure Packs

    FDA Enforcement
    Class II ·Terminated·Alcon Research, LLC·April 7, 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