BEUDAMED
    14 results · 21ms · Sources: EU EUDAMED, US FDA

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    ECLOS COMPUTED TOMOGRAPHY X-RAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SW

    FDA UDI
    SW SAFETY SOLUTIONS INC.·00616489125563·PowerChem Neoprene Exam Gloves, Extra Extra Large

    DELTA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·04546540337870·DELTA DRILL 1.8MM F.5/6MM SCREW, STRYKER

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111180545·TIP ONLY FOR YANKAUER 07-1805

    Acapella One

    FDA UDI
    Choice Spine, LP·00840996151399·ACAPELLA,TRIAL,CX,NS,14X18X6

    REFRACTIVE SURGERY BLADES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 26, 2025

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 5, 2022

    MARQUIS

    FDA Adverse Event
    Malfunction ·IPG MFG SWITZERLAND·Product code LWS·April 22, 2013

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Injury ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·April 21, 2011

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·July 8, 2008

    AxiEM EM Knee Kit, and associated workstation.

    FDA Recall
    Terminated ·Medtronic Navigation, Inc·Product code HAW·February 1, 2006

    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